Colon CancerNCT06362902
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
A study testing Laparoscopic right hemicolectomy with transrectal specimen extraction in people with Colon Cancer, run by National Cancer Center, China at 1 site in China.
Trial summary
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Laparoscopic right hemicolectomy with transrectal specimen extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven colon carcinoma;
- Imaging diagnosis of T1-3 colon cancer;
- The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
- Maximal tumor diameter ≤5 cm;
- Body mass index (BMI) ≤30 kg/m2;
- Written informed consent;
Who cannot join
- Complete intestinal obstruction;
- Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
- Pregnancy or breastfeeding;
- Alcohol abuse or drug addiction;
- Concurrent uncontrolled medical condition;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center
Beijing, Beijing Municipality, 100000
Haitao Zhou, M.D., +8613381167333, zhouhaitao01745@163.com
Yueyang Zhang, M.D., +8613552910035, yyzhang0129@163.com
About this study
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.
Read the detailed description
This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.
- Conditions
- Colon Cancer
- Being tested
- Laparoscopic right hemicolectomy with transrectal specimen extraction
- Keywords
- Colon cancer, Laparoscopic Right Hemicolectomy, Natural orifice specimen extraction surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right hemicolectomy with transrectal specimen extractionProcedure or surgery
Laparoscopic right hemicolectomy with transrectal specimen extraction
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction | Experimental | STEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision.
STEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler.
STEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision. Receives: Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of postoperative complications
The rate of postoperative complications = patients with any postoperative complications/all cases.
Measured: up to 30 days
Secondary outcomes (4)
Operating time
Operating time = The Operative time was defined as the time first skin incision was made to final skin closure
Measured: up to 1 days
Estimated blood loss
Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g)
Measured: up to 1 days
The time of first flatus
The time of first flatus = The time of first flatus reported by patients
Measured: up to 5 days
Postoperative hospitalization
Postoperative hospitalization = the number of nights from surgery to discharge
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitao Zhou, National Cancer Center, China
- Investigators
- Haitao Zhou, M.D., Study chair, National Cancer Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362902
- Sponsor's protocol ID
- NOSES-VIII B
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
- ClinicalTrials.gov ID
- NCT06362902
- Acronym / sponsor ID
- NOSES-VIII B
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Laparoscopic Right Hemicolectomy, Natural orifice specimen extraction surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- National Cancer Center, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.
Detailed description
This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction | Experimental | Procedure: Laparoscopic right hemicolectomy with transrectal specimen extractionSTEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision. STEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler. STEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy proven colon carcinoma;
- Imaging diagnosis of T1-3 colon cancer;
- The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
- Maximal tumor diameter ≤5 cm;
- Body mass index (BMI) ≤30 kg/m2;
Key exclusion criteria (6 listed)
- Complete intestinal obstruction;
- Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
- Pregnancy or breastfeeding;
- Alcohol abuse or drug addiction;
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 |
|---|---|---|
| Laparoscopic right hemicolectomy with transrectal specimen extractionLaparoscopic right hemicolectomy with transrectal specimen extraction | Procedure or surgery | Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction |
Primary outcome
The rate of postoperative complications
Time frame: up to 30 days
The rate of postoperative complications = patients with any postoperative complications/all cases.
4 secondary outcomes
Operating time
Time frame: up to 1 days
Estimated blood loss
Time frame: up to 1 days
The time of first flatus
Time frame: up to 5 days
Postoperative hospitalization
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No. Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
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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. This study is not recruiting at the moment.
Haitao Zhou, M.D. study chair
National Cancer Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic right hemicolectomy with transrectal specimen extraction in people with Colon Cancer, run by National Cancer Center, China at 1 site in China.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Xu, M.D. (+8618800157037, 1206164395@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of postoperative complications (time frame: up to 30 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 12 Apr 2024.