Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04324515
Other study ID # 2016-01243
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 18, 2018
Est. completion date March 1, 2022

Study information

Verified date March 2020
Source University of Geneva, Switzerland
Contact Minoa Jung, MD
Phone +41788497695
Email minoa.jung@hcuge.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

Read more »
Read more »

Study Design


Intervention

Procedure:
Robotic gastric bypass with or without cholecystectomy
Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy

Locations

Country Name City State
Switzerland Visceral Surgery, Department of Surgery, University Hospital Geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications Primary endpoint:
1. 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
within 30 days after intervention
Secondary Intraoperative adverse events in detail - Common bile duct lesion
- Lesion of Liver
- Lesion of digestive tract
- bleeding
- conversion
day of operation
Secondary 2. Morbidity and mortality 2. Morbidity and mortality assessed by Dindo/ Clavien Classification system 18 months
Secondary operation time length of operation time day of operation
Secondary 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) 6 months
Secondary gallstones occurence of asymptomatic or symptomatic gallstones 18 months
Secondary biliary complication cholecystitis, choledocholithiasis, cholangitis, biliary pancreatitis 18 months
Secondary cost average cost 18 months
Secondary EQ-5D-5L Quality of life using the EQ-5D-5L questionnaire 12 months
Secondary Readmission Readmission 18 months
Secondary Re intervention Re intervention (Cholecystectomy, transgastric ERCP, biliary Revision) 18 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04422236 - A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Withdrawn NCT04543526 - A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
Completed NCT01867255 - Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels Phase 1
Completed NCT04334161 - Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
Completed NCT03440138 - Defining Benchmarks in Bariatric Surgery
Completed NCT04972357 - Bariatric Procedures and Changes Gastric Passage
Active, not recruiting NCT03049696 - Does Participation in a Pre-Operative Physical Activity Program Improve Patient Outcomes and Quality of Life? N/A
Not yet recruiting NCT06350955 - IV Iron-induced Hypophosphatemia After RYGB Phase 4
Completed NCT02128581 - A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake Phase 1
Completed NCT03478098 - Meal Glycaemic Index and Exercise After Gastric Bypass N/A
Recruiting NCT04808206 - A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Completed NCT04600596 - Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass
Completed NCT04330196 - Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance. N/A
Completed NCT03968757 - Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
Active, not recruiting NCT02068001 - Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery N/A
Completed NCT02204813 - To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery Phase 1
Completed NCT05560789 - The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia N/A
Not yet recruiting NCT04172116 - Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass
Completed NCT04609449 - A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass N/A
Completed NCT05250271 - Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2 N/A