Viewing Study NCT04915014



Ignite Creation Date: 2024-05-06 @ 4:13 PM
Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04915014
Status: RECRUITING
Last Update Posted: 2023-12-27
First Post: 2021-05-19

Brief Title: Sleeve Gastrectomy With Transit BipartitionSGTB Versus Roux-en-Y Gastric Bypass RYGB for Type 3 Obesity
Sponsor: University Hospital Lille
Organization: University Hospital Lille

Study Overview

Official Title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition SGTB Versus Roux-en-Y Gastric Bypass RYGB
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BIPASS
Brief Summary: Obesity is a major public health problem worldwide Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up Sleeve Gastrectomy SG has become the most performed intervention either worldwide or in France where SG represents more than 60 of bariatric interventions and 114817 patients operated between 2013 and 2016

Maximum Excess weight loss EWL after SG is obtained at one-year post surgery Then it has been largely reported in the literature that patients could present mild moderate or important notably in the super obese patients weight regain associated with comorbidity relapse motivating redo surgery Like in revisional surgery operating super-obese patient BMI 50 kgm2 is a challenge It has been shown that achieving significant weight loss was more difficult in patients with a BMI 50 compared to lower BMIs
Detailed Description: In these 2 populations of patients more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce technical difficulties high complication rate and can be responsible for malnutrition vitamin deficiencies hypoalbuminemia Thats why in case of revisional surgery or for high BMI patientslaparoscopic Roux-en-Y gastric bypass RYGBP is still considered as the gold standard and is the most performed intervention To obtain better weight loss safelySantoro et al promoted the sleeve gastrectomy with transit bipartition SGTB a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP

Hypothesis Because there is no duodenal and jejunal exclusion malnutrition is expected to be less frequent after SGTB compared to BPDDS Its anastomosis on the antrum makes SGTB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss Compared to BPDDS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy SGTB is also expected to be easier then safer

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2020-A02656-33 OTHER None None
PHRC-19-031 OTHER DGOS number PHRC-N None