CholecystitisNCT04398810
Postoperative Pain Results According to Pressure to Form Pneumoperitoneum
A study testing robotic single port cholecystectomy in people with Cholecystitis and Postoperative Pain, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Cholecystitis, Postoperative Pain
- What is being tested?
- robotic single port cholecystectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2020to 30 Dec 2021
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent elective gallbladder surgery
- Cholelithiasis
- Chronic cholecystitis
- Gallbladder polyps
- Gallbladder adenoma
- Porcelain gallbladder
Who cannot join
- Acute cholecystitis patient group
- Necrotic gallbladder
- Collapsed gallbladder
- Gallbladder pustosis
- Gallbladder emphysema
- Hemorrhagic gallbladder
Show all 16Show fewer
- Perforated gallbladder
- cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
- cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder
- Patient group performing surgery concurrently due to other organ diseases
- Immunosuppressive patient group
- Transplant patient group: Liver transplant patient group (PSLT), Kidney transplant patient group (PSKT)
- AIDS patients group
- Patient group with history of open abdominal surgery
- Transplant group during open surgery
- Patients under 19 years of age.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701
Taeho Hong, MD, PhD, +82-2-2258-6108, gshth@catholic.ac.kr
About this study
Official title: A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.
This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed.
The primary purpose of the study was to compare the differences in the visual analog scale (VAS) between the two groups and to demonstrate the effectiveness of pain relief after surgery.
Secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.
Read the detailed description
Laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. Many patients complained pain around the wound, shoulder and back after surgery. Several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as NSAIDS, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, And active residual gas suction in the abdominal cavity had been found to relieve postoperative pain.
Robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. Based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum.
In this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.
- Conditions
- Cholecystitis, Postoperative Pain
- Being tested
- robotic single port cholecystectomy
- Keywords
- robot cholecystectomy, low-pressure pneumoperitoneum, postoperative pain
- Medical subject headings
- Cholecystitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic single port cholecystectomyProcedure or surgery
- Local anesthetic administration during wound incision In the experimental group and the control group, a local anesthetic was administered to the wound surface when a glove port was installed on the navel at the start of surgery. (bupivacaine 0.5% 14ml subcutaneous injection)
- Residual gas aspiration
- Pulmonary recruitment maneuver In both the experimental group and the control group, before the operation was completed and the wound was closed, the patient was taken to the Trenedelenburg position, and then the pressure of 60 cm H2o in the abdomen was applied, and manual inflation was performed twice, 5 seconds at a time, and pulmonary recruitment was performed.
- Warming of the washing solution in the abdominal cavity
| Study group | Role | What they receive |
|---|---|---|
| the low-pressure pneumoperitoneum during surgery | Experimental | A. Inclusion criteria Patients who underwent elective gallbladder surgery
* Cholelithiasis
* Chronic cholecystitis
* Gallbladder polyps
* Gallbladder adenoma
* Porcelain gallbladder
The experimental group controls the CO2 flow that is injected into the abdominal cavity during surgery and maintains the pressure in the abdominal cavity at a low level of 5 mmHg to perform the surgery. Receives: Procedure: robotic single port cholecystectomy |
| the standard-pressure pneumoperitoneum during surgery | Experimental | A. Inclusion criteria Patients who underwent elective gallbladder surgery
* Cholelithiasis
* Chronic cholecystitis
* Gallbladder polyps
* Gallbladder adenoma
* Porcelain gallbladder
In the case of the control group, surgery is performed while maintaining the pressure in the abdominal cavity at 12 mmHg as generally performed during surgery. Receives: Procedure: robotic single port cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score(VAS)
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 24 hours after surgery
Secondary outcomes (3)
postoperative complication
postoperative complication : bile leakage, atelectasis, pneumonia, wound infection, bleeding, etc..
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 days
hospital stay
hospital stay(days) : The duration between the operation day and the day of discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 days
operation time
operation time(minutes)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start2 Jun 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taeho Hong, Seoul St. Mary's Hospital
- Investigators
- Won jong Kim, MD, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398810
- Sponsor's protocol ID
- Seoul-09
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 21 May 2020
- Results posted
- 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04398810
- Acronym / sponsor ID
- Seoul-09
- Conditions
- Cholecystitis, Postoperative Pain
- Keywords
- robot cholecystectomy, low-pressure pneumoperitoneum, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 21 May 2020 (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.
This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed.
The primary purpose of the study was to compare the differences in the visual analog scale (VAS) between the two groups and to demonstrate the effectiveness of pain relief after surgery.
Secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.
Detailed description
Laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. Many patients complained pain around the wound, shoulder and back after surgery. Several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as NSAIDS, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, And active residual gas suction in the abdominal cavity had been found to relieve postoperative pain.
Robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. Based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum.
In this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the low-pressure pneumoperitoneum during surgery | Experimental | Procedure: robotic single port cholecystectomyA. Inclusion criteria Patients who underwent elective gallbladder surgery * Cholelithiasis * Chronic cholecystitis * Gallbladder polyps * Gallbladder adenoma * Porcelain gallbladder The experimental group controls the CO2 flow that is injected into the abdominal cavity during surgery and maintains the pressure in the abdominal cavity at a low level of 5 mmHg to perform the surgery. |
| the standard-pressure pneumoperitoneum during surgery | Experimental | Procedure: robotic single port cholecystectomyA. Inclusion criteria Patients who underwent elective gallbladder surgery * Cholelithiasis * Chronic cholecystitis * Gallbladder polyps * Gallbladder adenoma * Porcelain gallbladder In the case of the control group, surgery is performed while maintaining the pressure in the abdominal cavity at 12 mmHg as generally performed during surgery. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who underwent elective gallbladder surgery
- Cholelithiasis
- Chronic cholecystitis
- Gallbladder polyps
- Gallbladder adenoma
Key exclusion criteria (16 listed)
- Acute cholecystitis patient group
- cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
- cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder
- Patient group performing surgery concurrently due to other organ diseases
- Immunosuppressive patient group
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 |
|---|---|---|
| robotic single port cholecystectomy1. Local anesthetic administration during wound incision In the experimental group and the control group, a local anesthetic was administered to the wound surface when a glove port was installed on the navel at the start of surgery. (bupivacaine 0.5% 14ml subcutaneous injection) 2. Residual gas aspiration 3. Pulmonary recruitment maneuver In both the experimental group and the control group, before the operation was completed and the wound was closed, the patient was taken to the Trenedelenburg position, and then the pressure of 60 cm H2o in the abdomen was applied, and manual inflation was performed twice, 5 seconds at a time, and pulmonary recruitment was performed. 4. Warming of the washing solution in the abdominal cavity | Procedure or surgery | the low-pressure pneumoperitoneum during surgery, the standard-pressure pneumoperitoneum during surgery |
Primary outcome
Visual Analogue Score(VAS)
Time frame: 24 hours after surgery
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
3 secondary outcomes
postoperative complication
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
operation time
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- 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. This study is not recruiting at the moment.
Won jong Kim, MD study director
The Catholic University of 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 robotic single port cholecystectomy in people with Cholecystitis and Postoperative Pain, run by Seoul St. Mary's Hospital 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 6 inclusion and 16 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 21 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae ho Hong, MD. PhD (+82-10-5206-5266, gshth@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score(VAS) (time frame: 24 hours after surgery). 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 21 May 2020.