Roux-en-Y Gastric BypassNCT04324515
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
A study testing Robotic gastric bypass with or without cholecystectomy in people with Roux-en-Y Gastric Bypass and Cholecystitis; Gallstone, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Roux-en-Y Gastric Bypass, Cholecystitis; Gallstone, Gallbladder Diseases
- What is being tested?
- Robotic gastric bypass with or without cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jul 2018to 1 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must meet the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19):
- BMI ≥ 35 kg/m2
- Having followed a 2 year adequate program of weight loss without success or a 1 year program in case of "superobesity" (BMI ≥ 50 kg/m2)
- Consent to multidisciplinary follow up for 5 years
- Preoperative ultrasound without presence of gallstones or polyps
- Age ≥ 18 years
Who cannot join
- Patients which have a contra-indication for gastric bypass according to the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19):
- Pregnancy
- Kidney failure (creatinine ≥ 300mmol/l, GFR < 30ml/min) without dialysis
- Cirrhosis Child B/C
- Ulcerative Colitis
- Pulmonary embolism or deep venous thrombosis during the last 6 months
Show all 15Show fewer
- Psychiatric contra indications
- Drug abuse (alcohol, cannabis, opioids) during the last 6 months
- Presence of gallstones on preoperative Ultrasound (which will require concomitant cholecystectomy)
- Patients with clinical diagnosis of cholecystitis defined as right upper quadrant abdominal pain, radiological signs of cholecystits and laboratory signs of infection or gallstone migration, defined as right upper quadrant and abnormal liver function tests (any increase in AST, ALT, alkaline Phosphatase, GGT and/or bilirubin).
- Previous bariatric surgery other than gastric banding
- Open bypass procedure
- Medical conditions preventing informed consent
- Preoperative routine work-up includes a physical examination, vital parameters, laboratory analyses (hematology, chemistry and HbA1c), sleep apnea evaluation with Polygraphia, abdominal ultrasound, endoscopy of the stomach, pulmonary function, preoperative anesthesia consultation and psychological evaluation.
- The results of these routine tests will be used to assess the patients'eligiibility to participate to the proposed pilot study.
Trial locations and contacts
1 site in 1 country.
Marion Dietrich contact
Switzerland1 site, 1 recruiting
- Recruiting
Visceral Surgery, Department of Surgery, University Hospital Geneva
Geneva, 1206
Marion Dietrich, marion.dietrich@hcuge.ch
Minoa Jung, MD, +41795534416, minoa.jung@hcuge.ch
About this study
Official title: Pilot Open Randomized Controlled Trial Comparing Patients Undergoing Robotic Gastric Bypass With or Without Concomitant Cholecystectomy
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.
Read the detailed description
We suggest performing a prospective randomized pilot trial comparing RYGB without concomitant cholecystectomy with RYGB with concomitant cholecystectomy for patients with absence of gallstones in preoperative ultrasound. Patients with ultrasonographically confirmed gallstones in the gallbladder undergo concomitant cholecystectomy at time of RYGB and are excluded from the study.Patients who meet the inclusion criteria will be randomized according to a randomization list generated by the CRC of the University Hospital of Geneva. The randomization envelops will be opened by the study staff at the appropriate time prior to the scheduling of gastric bypass after subject selection. The randomization assignment insert will contain information specifying whether the cholecystectomy will be performed or not during gastric bypass procedure.
A total of 90 consecutive obese patients attending the Unit of Visceral Surgery of the University Hospital of Geneva who meet the criteria for bariatric surgery and where the preoperative ultrasound confirms absence of gallstones will be recruited for the study.
A prospective open randomized pilot study design will be used. At 6 follow-up visits (at discharge, 1 ,3 ,6 ,12 and 18 months post-surgery), patients will be evaluated.
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 as wella s all national legal and regulatory requirements, the LPth (Loi sur les produits thérapeutiques 812.21) and the OClin (Ordonnance sur les essais cliniques des produits thérapeutiques 812.214.2).
Description of surgical technique One optical trocar, three 12 mm trocars and one 5 mm trocar are placed. No additional trocar has to be placed for concomitant cholecystectomy. The intervention will start with the cholecystectomy laparoscopically. A small gastric pouch (around 20-30 cc) is created using blue cartridge staplers. A standard robotic RYGB with a 75 cm biliary limb and a 150 cm antecolic alimentary limb is performed. A hand-sewn gastrojejunal and jejunojejunal anastomois are performed, using a single layer running suture of Vicryl 2.0.
Data Collection:
Pre-Operative demographic data and other variables will be collected at baseline and at some of the 6 follow-up points (at discharge, 1,3,6,12,18 months):
Ultrasound, Patient Demographics and pre-Operative History will be collected, including: Gender, age on admission for operation, BMI, Height, Weight, ASA score, history of abdominal surgery, co- morbidities (Type 2 diabetes requiring Insulin or oral medication), Hypertension requiring medication, Coronary heart disease, including history of myocardial infarction, angina pectoris, coronary artery surgery Pulmonary comorbidities including history of pulmonary embolism, Sleep Apnea Tobacco use, Medication used by patient, Systolic and diastolic blood pressure, heart rate, Fasting plasma glucose, HbA1c, laboratory findings, QOL using the EQ-5D-5L questionnaire
Intra-Operative Assessment: Intra-Operative data such as complications (organ lesion, bleeding, conversion), operative time, docking times, estimated blood loss will be collected
Post-Operative Assessment: From surgery to discharge, the following patient information will be collected: complications according to Clavien/Dindo Classification system, re- operation, re-admission, length of hospital stay
Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up.
- Being tested
- Robotic gastric bypass with or without cholecystectomy
- Medical subject headings
- Cholecystitis, Gallstones, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic gastric bypass with or without cholecystectomyProcedure or surgery
Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Study Arm without cholecystectomy | Other | Study Arm: Patients with gastric bypass without concomitant cholecystectomy Receives: Procedure: Robotic gastric bypass with or without cholecystectomy |
| Control Arm with cholecystectomy | Other | Control Arm: Patients with gastric bypass with concomitant cholecystectomy Receives: Procedure: Robotic gastric bypass with or without cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications
Primary endpoint:
- composite endpoint consisting of:
- : intraoperative adverse events (common bile duct lesion, lesion of liver, lesion of digestive tract, bleeding, conversion).
- : postoperative complications according to Dindo/Clavien Classification
Measured: within 30 days after intervention
Secondary outcomes (10)
Intraoperative adverse events in detail
- - Common bile duct lesion
- - Lesion of Liver
- - Lesion of digestive tract
- - bleeding
- - conversion
Measured: day of operation
2. Morbidity and mortality
- Morbidity and mortality assessed by Dindo/ Clavien Classification system
Measured: 18 months
operation time
length of operation time
Measured: day of operation
hospital stay
length of hospital stay (discharge criteria defined as follows : absence of fever (T≤37.8), Neutrophils ≤12G/L, Absence of anemia, no nausea, no vomiting)
Measured: 6 months
gallstones
occurence of asymptomatic or symptomatic gallstones
Measured: 18 months
biliary complication
cholecystitis, choledocholithiasis, cholangitis, biliary pancreatitis
Measured: 18 months
cost
average cost
Measured: 18 months
EQ-5D-5L
Quality of life using the EQ-5D-5L questionnaire
Measured: 12 months
Readmission
Readmission
Measured: 18 months
Re intervention
Re intervention (Cholecystectomy, transgastric ERCP, biliary Revision)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start18 Jul 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Roux-en-Y Gastric BypassStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who meet the inclusion criteria will be randomized according to a randomization list generated by the CRC of the University Hospital of Geneva. The randomization envelops will be opened by the study staff at the appropriate time prior to the scheduling of gastric bypass after subject selection. The randomization assignment insert will contain information specifying whether the cholecystectomy will be performed or not during gastric bypass procedure.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Minoa, University of Geneva, Switzerland
- Investigators
- Minoa Jung, Dr, Principal investigator, Visceral Surgery, Department of Surgery, University Hospital of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324515
- Sponsor's protocol ID
- 2016-01243
- Other IDs
- 2016
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason EE, Renquist KE. Gallbladder management in obesity surgery. Obes Surg. 2002 Apr;12(2):222-9. doi: 10.1381/096089202762552395.
PubMed 11975217Schmidt JH, Hocking MP, Rout WR, Woodward ER. The case for prophylactic cholecystectomy concomitant with gastric restriction for morbid obesity. Am Surg. 1988 May;54(5):269-72.
PubMed 3364862Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.
PubMed 1858735Everhart JE. Contributions of obesity and weight loss to gallstone disease. Ann Intern Med. 1993 Nov 15;119(10):1029-35. doi: 10.7326/0003-4819-119-10-199311150-00010.
PubMed 8214980Worni M, Guller U, Shah A, Gandhi M, Shah J, Rajgor D, Pietrobon R, Jacobs DO, Ostbye T. Cholecystectomy concomitant with laparoscopic gastric bypass: a trend analysis of the nationwide inpatient sample from 2001 to 2008. Obes Surg. 2012 Feb;22(2):220-9. doi: 10.1007/s11695-011-0575-y.
PubMed 22183984Patel KR, White SC, Tejirian T, Han SH, Russell D, Vira D, Liao L, Patel KB, Gracia C, Haigh P, Dutson E, Mehran A. Gallbladder management during laparoscopic Roux-en-Y gastric bypass surgery: routine preoperative screening for gallstones and postoperative prophylactic medical treatment are not necessary. Am Surg. 2006 Oct;72(10):857-61.
PubMed 17058721Weinsier RL, Ullmann DO. Gallstone formation and weight loss. Obes Res. 1993 Jan;1(1):51-6. doi: 10.1002/j.1550-8528.1993.tb00008.x.
PubMed 16350561Wudel LJ Jr, Wright JK, Debelak JP, Allos TM, Shyr Y, Chapman WC. Prevention of gallstone formation in morbidly obese patients undergoing rapid weight loss: results of a randomized controlled pilot study. J Surg Res. 2002 Jan;102(1):50-6. doi: 10.1006/jsre.2001.6322.
PubMed 11792152Warschkow R, Tarantino I, Ukegjini K, Beutner U, Guller U, Schmied BM, Muller SA, Schultes B, Thurnheer M. Concomitant cholecystectomy during laparoscopic Roux-en-Y gastric bypass in obese patients is not justified: a meta-analysis. Obes Surg. 2013 Mar;23(3):397-407. doi: 10.1007/s11695-012-0852-4.
PubMed 23315094Villegas L, Schneider B, Provost D, Chang C, Scott D, Sims T, Hill L, Hynan L, Jones D. Is routine cholecystectomy required during laparoscopic gastric bypass? Obes Surg. 2004 Jan;14(1):60-6. doi: 10.1381/096089204772787301.
PubMed 14980035Tucker ON, Fajnwaks P, Szomstein S, Rosenthal RJ. Is concomitant cholecystectomy necessary in obese patients undergoing laparoscopic gastric bypass surgery? Surg Endosc. 2008 Nov;22(11):2450-4. doi: 10.1007/s00464-008-9769-3. Epub 2008 Feb 21.
PubMed 18288531Buchs NC, Morel P, Azagury DE, Jung M, Chassot G, Huber O, Hagen ME, Pugin F. Laparoscopic versus robotic Roux-en-Y gastric bypass: lessons and long-term follow-up learned from a large prospective monocentric study. Obes Surg. 2014 Dec;24(12):2031-9. doi: 10.1007/s11695-014-1335-6.
PubMed 24962109Burgard M, Bonino M, Dietrich M, Iranmanesh P, Racine M, Giudicelli G, Monig SP, Toso C, Jung MK. Robotic gastric Roux-en-Y bypass with or without concomitant cholecystectomy: pilot open label randomized trial. BJS Open. 2026 Jul 3;10(4):zrag092. doi: 10.1093/bjsopen/zrag092.
PubMed 42610981
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open Randomized Controlled Trial Comparing Patients Undergoing Robotic Gastric Bypass With or Without Concomitant Cholecystectomy
- ClinicalTrials.gov ID
- NCT04324515
- Acronym / sponsor ID
- 2016-01243
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Mar 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.
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.
Detailed description
We suggest performing a prospective randomized pilot trial comparing RYGB without concomitant cholecystectomy with RYGB with concomitant cholecystectomy for patients with absence of gallstones in preoperative ultrasound. Patients with ultrasonographically confirmed gallstones in the gallbladder undergo concomitant cholecystectomy at time of RYGB and are excluded from the study.Patients who meet the inclusion criteria will be randomized according to a randomization list generated by the CRC of the University Hospital of Geneva. The randomization envelops will be opened by the study staff at the appropriate time prior to the scheduling of gastric bypass after subject selection. The randomization assignment insert will contain information specifying whether the cholecystectomy will be performed or not during gastric bypass procedure.
A total of 90 consecutive obese patients attending the Unit of Visceral Surgery of the University Hospital of Geneva who meet the criteria for bariatric surgery and where the preoperative ultrasound confirms absence of gallstones will be recruited for the study.
A prospective open randomized pilot study design will be used. At 6 follow-up visits (at discharge, 1 ,3 ,6 ,12 and 18 months post-surgery), patients will be evaluated.
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 as wella s all national legal and regulatory requirements, the LPth (Loi sur les produits thérapeutiques 812.21) and the OClin (Ordonnance sur les essais cliniques des produits thérapeutiques 812.214.2).
Description of surgical technique One optical trocar, three 12 mm trocars and one 5 mm trocar are placed. No additional trocar has to be placed for concomitant cholecystectomy. The intervention will start with the cholecystectomy laparoscopically. A small gastric pouch (around 20-30 cc) is created using blue cartridge staplers. A standard robotic RYGB with a 75 cm biliary limb and a 150 cm antecolic alimentary limb is performed. A hand-sewn gastrojejunal and jejunojejunal anastomois are performed, using a single layer running suture of Vicryl 2.0.
Data Collection:
Pre-Operative demographic data and other variables will be collected at baseline and at some of the 6 follow-up points (at discharge, 1,3,6,12,18 months):
Ultrasound, Patient Demographics and pre-Operative History will be collected, including: Gender, age on admission for operation, BMI, Height, Weight, ASA score, history of abdominal surgery, co- morbidities (Type 2 diabetes requiring Insulin or oral medication), Hypertension requiring medication, Coronary heart disease, including history of myocardial infarction, angina pectoris, coronary artery surgery Pulmonary comorbidities including history of pulmonary embolism, Sleep Apnea Tobacco use, Medication used by patient, Systolic and diastolic blood pressure, heart rate, Fasting plasma glucose, HbA1c, laboratory findings, QOL using the EQ-5D-5L questionnaire
Intra-Operative Assessment: Intra-Operative data such as complications (organ lesion, bleeding, conversion), operative time, docking times, estimated blood loss will be collected
Post-Operative Assessment: From surgery to discharge, the following patient information will be collected: complications according to Clavien/Dindo Classification system, re- operation, re-admission, length of hospital stay
Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who meet the inclusion criteria will be randomized according to a randomization list generated by the CRC of the University Hospital of Geneva. The randomization envelops will be opened by the study staff at the appropriate time prior to the scheduling of gastric bypass after subject selection. The randomization assignment insert will contain information specifying whether the cholecystectomy will be performed or not during gastric bypass procedure.
| Arm | Type | Receives |
|---|---|---|
| Study Arm without cholecystectomy | Other | Procedure: Robotic gastric bypass with or without cholecystectomyStudy Arm: Patients with gastric bypass without concomitant cholecystectomy |
| Control Arm with cholecystectomy | Other | Procedure: Robotic gastric bypass with or without cholecystectomyControl Arm: Patients with gastric bypass with concomitant cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19):
- Preoperative ultrasound without presence of gallstones or polyps
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- Patients which have a contra-indication for gastric bypass according to the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19):
- Presence of gallstones on preoperative Ultrasound (which will require concomitant cholecystectomy)
- Patients with clinical diagnosis of cholecystitis defined as right upper quadrant abdominal pain, radiological signs of cholecystits and laboratory signs of infection or gallstone migration, defined as right upper quadrant and abnormal liver function tests (any increase in AST, ALT, alkaline Phosphatase, GGT and/or bilirubin).
- Previous bariatric surgery other than gastric banding
- Open bypass procedure
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 gastric bypass with or without cholecystectomyStudy Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy | Procedure or surgery | Control Arm with cholecystectomy, Study Arm without cholecystectomy |
Primary outcome
Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications
Time frame: within 30 days after intervention
Primary endpoint: 1. composite endpoint consisting of: 1. : intraoperative adverse events (common bile duct lesion, lesion of liver, lesion of digestive tract, bleeding, conversion). 2. : postoperative complications according to Dindo/Clavien Classification
10 secondary outcomes
Intraoperative adverse events in detail
Time frame: day of operation
2. Morbidity and mortality
Time frame: 18 months
operation time
Time frame: day of operation
hospital stay
Time frame: 6 months
gallstones
Time frame: 18 months
biliary complication
Time frame: 18 months
cost
Time frame: 18 months
EQ-5D-5L
Time frame: 12 months
Readmission
Time frame: 18 months
Re intervention
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Results publication: PubMed 11975217Mason EE, Renquist KE. Gallbladder management in obesity surgery. Obes Surg. 2002 Apr;12(2):222-9. doi: 10.1381/096089202762552395.
- Results publication: PubMed 3364862Schmidt JH, Hocking MP, Rout WR, Woodward ER. The case for prophylactic cholecystectomy concomitant with gastric restriction for morbid obesity. Am Surg. 1988 May;54(5):269-72.
- Results publication: PubMed 1858735Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.
- Results publication: PubMed 8214980Everhart JE. Contributions of obesity and weight loss to gallstone disease. Ann Intern Med. 1993 Nov 15;119(10):1029-35. doi: 10.7326/0003-4819-119-10-199311150-00010.
- Results publication: PubMed 22183984Worni M, Guller U, Shah A, Gandhi M, Shah J, Rajgor D, Pietrobon R, Jacobs DO, Ostbye T. Cholecystectomy concomitant with laparoscopic gastric bypass: a trend analysis of the nationwide inpatient sample from 2001 to 2008. Obes Surg. 2012 Feb;22(2):220-9. doi: 10.1007/s11695-011-0575-y.
- Results publication: PubMed 17058721Patel KR, White SC, Tejirian T, Han SH, Russell D, Vira D, Liao L, Patel KB, Gracia C, Haigh P, Dutson E, Mehran A. Gallbladder management during laparoscopic Roux-en-Y gastric bypass surgery: routine preoperative screening for gallstones and postoperative prophylactic medical treatment are not necessary. Am Surg. 2006 Oct;72(10):857-61.
- Results publication: PubMed 16350561Weinsier RL, Ullmann DO. Gallstone formation and weight loss. Obes Res. 1993 Jan;1(1):51-6. doi: 10.1002/j.1550-8528.1993.tb00008.x.
- Results publication: PubMed 11792152Wudel LJ Jr, Wright JK, Debelak JP, Allos TM, Shyr Y, Chapman WC. Prevention of gallstone formation in morbidly obese patients undergoing rapid weight loss: results of a randomized controlled pilot study. J Surg Res. 2002 Jan;102(1):50-6. doi: 10.1006/jsre.2001.6322.
- Results publication: PubMed 23315094Warschkow R, Tarantino I, Ukegjini K, Beutner U, Guller U, Schmied BM, Muller SA, Schultes B, Thurnheer M. Concomitant cholecystectomy during laparoscopic Roux-en-Y gastric bypass in obese patients is not justified: a meta-analysis. Obes Surg. 2013 Mar;23(3):397-407. doi: 10.1007/s11695-012-0852-4.
- Results publication: PubMed 14980035Villegas L, Schneider B, Provost D, Chang C, Scott D, Sims T, Hill L, Hynan L, Jones D. Is routine cholecystectomy required during laparoscopic gastric bypass? Obes Surg. 2004 Jan;14(1):60-6. doi: 10.1381/096089204772787301.
- Results publication: PubMed 18288531Tucker ON, Fajnwaks P, Szomstein S, Rosenthal RJ. Is concomitant cholecystectomy necessary in obese patients undergoing laparoscopic gastric bypass surgery? Surg Endosc. 2008 Nov;22(11):2450-4. doi: 10.1007/s00464-008-9769-3. Epub 2008 Feb 21.
- Results publication: PubMed 24962109Buchs NC, Morel P, Azagury DE, Jung M, Chassot G, Huber O, Hagen ME, Pugin F. Laparoscopic versus robotic Roux-en-Y gastric bypass: lessons and long-term follow-up learned from a large prospective monocentric study. Obes Surg. 2014 Dec;24(12):2031-9. doi: 10.1007/s11695-014-1335-6.
- 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.
Marion Dietrich contact
Minoa Jung, Dr principal investigator
Visceral Surgery, Department of Surgery, University Hospital of Geneva
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 gastric bypass with or without cholecystectomy in people with Roux-en-Y Gastric Bypass and Cholecystitis; Gallstone, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 15 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 27 Mar 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 Switzerland. 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 Minoa Jung, MD (+41788497695, minoa.jung@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications (time frame: within 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324515, which also lists 13 linked publications.
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 27 Mar 2020.