Adenocarcinoma of the ColonNCT07129512
Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Adenocarcinoma of the Colon, run by Yonsei University at 1 site in South Korea.
Trial summary
INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Adenocarcinoma of the Colon
- What is being tested?
- Intracorporeal anastomosis and Extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 19 to 80 years of age
- Patients with histologically confirmed pathologic adenocarcinoma of the colon
- Patients with an ECOG score between 0 and 2
- Patients with a preoperative ASA score of I to III
- Patients without a history of surgery for abdominal malignancies
- Patients with no history of anticoagulation prior to surgery
- Patients who understand the study process and treatment plan and are able to complete the informed consent form themselves
Who cannot join
- Patients with an ASA score of 4 or higher
- People with blood clotting disorders such as liver cirrhosis, end-stage renal failure, or hematologic disorders
- Pregnant women
- Mentally ill patients who have difficulty giving informed consent
- Preoperative blood hemoglobin (Hb) less than 7 g/dL
- Patients taking anticoagulants before or after surgery
Show all 9Show fewer
- Patients who have undergone emergency surgery
- Patients who are unable to be followed up on an outpatient basi
- No Informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul
Byung Soh Min, MD, PhD., 82-2-2228-2100, bsmin@yuhs.ac
About this study
Official title: Clipless Ultrasonic Energy-based Hemostasis Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery: A Pilot Study
INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Ultrasonic scalpels offer a safer alternative, approved for various surgeries, but their efficacy in colorectal cancer surgery needs prospective validation.
STUDY OBJECTIVE Study compares safety/efficacy of clipless vs. clip-type hemostasis using ultrasonic scalpel in colorectal surgery, focusing on post-op bleeding frequency, intraoperative bleed, drainage, hospital stay.
Read more
STUDY DESIGN This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study's experimental group undergoes surgery with an ultrasonic scalpel, while the control group receives treatment with a monopolar energy device and clips. Allocation to groups, using a 1:1 ratio, is randomized via a computerized table by a blinded coordinator, immediately post-anesthesia. Principal investigators and administrators remain blinded throughout the study.
STUDY POPULATION
- Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with colonic adenocarcinoma and are subject to a colectomy procedure.
All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.
RISK ANALYSIS The surgical procedure, postoperative care, and follow-up will be the same for the experitmental and control groups in this study. The use of the ultrasonic scalpel alone may prevent complications such as clip-induced intestinal obstruction, infection, bleeding from clip dislodgement, bile leakage, and infection, but there is no additional benefit for other subjects. The risk of bleeding when ligating vessels with an ultrasonic scalpel has been demonstrated to be safe in retrospective studies for vessels 7 mm or less (8-17). Vessels larger than 7 mm are ligated using surgical clips because the safety of ligation with the ultrasound scalpel has not been studied. Based on the reported safety of this method of ligation, the risks do not outweigh the benefits when analyzed in the aggregate.
QUALIFICATION OF PARTICIPATING SURGEONS
- Surgical procedure
- Laparoscopic surgery: Surgery for colorectal cancer consists of ligating blood vessels to the lesion, detaching or mobilizing the colon, and resecting and anastomosing the bowel.
- Clipless ultrasound energy-based hemostasis arm: the ultrasound scalpel is used to dissect and ligate the vessel, but clips are used for vessels larger than 7 mm in diameter. If there is significant bleeding during the procedure, surgical clips and hemostatic agents may be used for patient safety at the discretion of the surgeon.
- Control arm: a combination of monopolar cautery and surgical clips will be used for vascular ligation and lymph node dissection.
- Procedure standardization and qualification procedure This study is about laparoscopic surgery for colorectal cancer and all surgeries will be performed by surgeons with at least 100 laparoscopic colorectal cancer surgeries.
STATISTICAL ANALYSIS This study compares the frequency of postoperative bleeding between clipless and clip-type ultrasound energy hemostasis in laparoscopic colorectal cancer surgery, assuming that there will be deviations from randomization, such as switching of surgical groups after randomization or additional vessel ligation with clips during or after surgery, we will perform a per-protocol analysis.
The missing values of postoperative bleeding, intraoperative blood loss, intraoperative blood transfusion, and conversion to laparotomy are assumed to be none, and the missing values of postoperative drainage tube hematocrit and drainage tube triglycerides are converted to the mean values of the same group. Outliers will be retained without replacement for intraoperative blood loss, operative time, maximum postoperative plasma hemoglobin decline, and total drainage volume within 5 days postoperatively.
For Type 1 errors, the frequency of postoperative intra-abdominal bleeding in the control group will be analyzed during data safety monitoring every 50 cases to ensure that it is less than 0.5-4.5% according to the literature.
Read the detailed description
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
- Conditions
- Adenocarcinoma of the Colon
- Being tested
- Intracorporeal anastomosis, Extracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
In this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode.
Extracorporeal anastomosisProcedure or surgery
In this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips.
| Study group | Role | What they receive |
|---|---|---|
| Clipless ultrasonic energy-based hemostasis | Experimental | In this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode. Receives: Procedure: Intracorporeal anastomosis |
| Conventional clipping hemostasis | Active comparator | In this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips. Receives: Procedure: Extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative intra-abdominal bleeding with Clavien-Dindo grade II or higher
Evaluation of the presence of intra-abdominal bleeding after surgery for Clavien-Dindo grade II or greater is considered positive if any of the following are satisfied within postoperative 30 days
- Blood transfusion was performed because of suspected intra-abdominal bleeding.
- A contrast-enhanced abdominal pelvic tomogram performed for suspected intra-abdominal hemorrhage demonstrates contrast leakage or the presence of a hemoperitoneum.
- Angiographic thromboembolization for intra-abdominal bleeding.
- Reoperation for intra-abdominal bleeding.
Measured: within 30 postoperative days
Secondary outcomes (9)
Intraoperative blood loss (estimated blood loss, ml)
Volume of blood lost during the surgical procedure, estimated by the anesthesiologist based on suction canister volume and surgical field assessment, excluding irrigation fluid.
Measured: intraoperative
intraoperative blood transfusion
Whether the participant received any transfusion of packed red blood cells, fresh frozen plasma, or platelets during surgery, as documented in anesthesia and operative records.
Measured: intraoperative
conversion to laparotomy
Whether laparoscopic surgery was converted to open laparotomy for any reason, including uncontrolled bleeding, poor exposure, or intraoperative injury.
Measured: intraoperative
operative time
Total duration of the surgical procedure from skin incision to wound closure, recorded in operative notes.
Measured: intraoperative
postoperative plasma hemoglobin maximum decrease (mg/dL)
Largest drop in hemoglobin concentration compared with the preoperative baseline, measured from postoperative blood samples.
Measured: 5 days
total drainage tube volume (ml) within 5 days postoperatively
Cumulative drainage output from the indwelling drain over the first 5 postoperative days, measured daily and summed.
Measured: 5 days
postoperative drainage tube hematocrit (Hct) (maximum value)
Highest hematocrit value measured from drainage fluid samples during the first 5 postoperative days.
Measured: 5 days
drainage tube triglyceride (TG) (maximum value)
Highest triglyceride concentration measured from drainage fluid samples during the first 5 postoperative days.
Measured: 5 days
complications within 30 days postoperatively
Any postoperative adverse event graded using the Clavien-Dindo classification. Report both overall complications (any grade) and clinically significant complications (grade ≥ II). Data obtained from inpatient records and outpatient follow-up within 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start4 Mar 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion24 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study subjects will be randomly assigned to: 1. clipless ultrasonic energy-based hemostasis 2. conventional clipping hemostasis
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129512
- Sponsor's protocol ID
- 4-2023-1029
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clipless Ultrasonic Energy-based Hemostasis Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT07129512
- Acronym / sponsor ID
- 4-2023-1029
- Conditions
- Adenocarcinoma of the Colon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 24 Sep 2025 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Ultrasonic scalpels offer a safer alternative, approved for various surgeries, but their efficacy in colorectal cancer surgery needs prospective validation.
STUDY OBJECTIVE Study compares safety/efficacy of clipless vs. clip-type hemostasis using ultrasonic scalpel in colorectal surgery, focusing on post-op bleeding frequency, intraoperative bleed, drainage, hospital stay.
STUDY DESIGN This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study's experimental group undergoes surgery with an ultrasonic scalpel, while the control group receives treatment with a monopolar energy device and clips. Allocation to groups, using a 1:1 ratio, is randomized via a computerized table by a blinded coordinator, immediately post-anesthesia. Principal investigators and administrators remain blinded throughout the study.
STUDY POPULATION
- Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with colonic adenocarcinoma and are subject to a colectomy procedure.
All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.
RISK ANALYSIS The surgical procedure, postoperative care, and follow-up will be the same for the experitmental and control groups in this study. The use of the ultrasonic scalpel alone may prevent complications such as clip-induced intestinal obstruction, infection, bleeding from clip dislodgement, bile leakage, and infection, but there is no additional benefit for other subjects. The risk of bleeding when ligating vessels with an ultrasonic scalpel has been demonstrated to be safe in retrospective studies for vessels 7 mm or less (8-17). Vessels larger than 7 mm are ligated using surgical clips because the safety of ligation with the ultrasound scalpel has not been studied. Based on the reported safety of this method of ligation, the risks do not outweigh the benefits when analyzed in the aggregate.
QUALIFICATION OF PARTICIPATING SURGEONS
- Surgical procedure
- Laparoscopic surgery: Surgery for colorectal cancer consists of ligating blood vessels to the lesion, detaching or mobilizing the colon, and resecting and anastomosing the bowel.
- Clipless ultrasound energy-based hemostasis arm: the ultrasound scalpel is used to dissect and ligate the vessel, but clips are used for vessels larger than 7 mm in diameter. If there is significant bleeding during the procedure, surgical clips and hemostatic agents may be used for patient safety at the discretion of the surgeon.
- Control arm: a combination of monopolar cautery and surgical clips will be used for vascular ligation and lymph node dissection.
- Procedure standardization and qualification procedure This study is about laparoscopic surgery for colorectal cancer and all surgeries will be performed by surgeons with at least 100 laparoscopic colorectal cancer surgeries.
STATISTICAL ANALYSIS This study compares the frequency of postoperative bleeding between clipless and clip-type ultrasound energy hemostasis in laparoscopic colorectal cancer surgery, assuming that there will be deviations from randomization, such as switching of surgical groups after randomization or additional vessel ligation with clips during or after surgery, we will perform a per-protocol analysis.
The missing values of postoperative bleeding, intraoperative blood loss, intraoperative blood transfusion, and conversion to laparotomy are assumed to be none, and the missing values of postoperative drainage tube hematocrit and drainage tube triglycerides are converted to the mean values of the same group. Outliers will be retained without replacement for intraoperative blood loss, operative time, maximum postoperative plasma hemoglobin decline, and total drainage volume within 5 days postoperatively.
For Type 1 errors, the frequency of postoperative intra-abdominal bleeding in the control group will be analyzed during data safety monitoring every 50 cases to ensure that it is less than 0.5-4.5% according to the literature.
Detailed description
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
STUDY METHODS
- Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
- Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 18 months. The study subjects will have a short-term follow-up at 30 days after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
- Randomization A computerized random number table allocating subjects to treatment and control groups in a 1:1 ratio will be administered by a clinically blinded study coordinator, and allocation will be performed immediately after anesthesia in the operating room on the day of surgery. The principal investigator and administrator will be blinded.
- Data collection Data will be collected at baseline, post-operative, discharge and 1 month. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
- Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent. Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
- Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study subjects will be randomly assigned to: 1. clipless ultrasonic energy-based hemostasis 2. conventional clipping hemostasis
| Arm | Type | Receives |
|---|---|---|
| Clipless ultrasonic energy-based hemostasis | Experimental | Procedure: Intracorporeal anastomosisIn this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode. |
| Conventional clipping hemostasis | Active comparator | Procedure: Extracorporeal anastomosisIn this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 19 to 80 years of age
- Patients with histologically confirmed pathologic adenocarcinoma of the colon
- Patients with an ECOG score between 0 and 2
- Patients with a preoperative ASA score of I to III
- Patients without a history of surgery for abdominal malignancies
Key exclusion criteria (9 listed)
- Patients with an ASA score of 4 or higher
- People with blood clotting disorders such as liver cirrhosis, end-stage renal failure, or hematologic disorders
- Pregnant women
- Mentally ill patients who have difficulty giving informed consent
- Preoperative blood hemoglobin (Hb) less than 7 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracorporeal anastomosisIn this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode. | Procedure or surgery | Clipless ultrasonic energy-based hemostasis |
| Extracorporeal anastomosisIn this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips. | Procedure or surgery | Conventional clipping hemostasis |
Primary outcome
Frequency of postoperative intra-abdominal bleeding with Clavien-Dindo grade II or higher
Time frame: within 30 postoperative days
Evaluation of the presence of intra-abdominal bleeding after surgery for Clavien-Dindo grade II or greater is considered positive if any of the following are satisfied within postoperative 30 days 1. Blood transfusion was performed because of suspected intra-abdominal bleeding. 2. A contrast-enhanced abdominal pelvic tomogram performed for suspected intra-abdominal hemorrhage demonstrates contrast leakage or the presence of a hemoperitoneum. 3. Angiographic thromboembolization for intra-abdominal bleeding. 4. Reoperation for intra-abdominal bleeding.
9 secondary outcomes
Intraoperative blood loss (estimated blood loss, ml)
Time frame: intraoperative
intraoperative blood transfusion
Time frame: intraoperative
conversion to laparotomy
Time frame: intraoperative
operative time
Time frame: intraoperative
postoperative plasma hemoglobin maximum decrease (mg/dL)
Time frame: 5 days
total drainage tube volume (ml) within 5 days postoperatively
Time frame: 5 days
postoperative drainage tube hematocrit (Hct) (maximum value)
Time frame: 5 days
drainage tube triglyceride (TG) (maximum value)
Time frame: 5 days
complications within 30 days postoperatively
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Adenocarcinoma of the Colon, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of postoperative intra-abdominal bleeding with Clavien-Dindo grade II or higher (time frame: within 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.