CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,741 enrolled
Drug / intervention
bariatric surgery (RYGB or SG)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03440138
NCT03440138N/ACompleted

Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy

Marco Bueter·observational·Posted Feb 20, 2018·Updated Sep 19, 2019

In Brief

An observational study evaluating bariatric surgery (RYGB or SG) for Benchmark and 4 related conditions. Completed, enrolled 5,741 participants across 1 site.

Detailed Summary

Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery. Design: Multicenter retrospective cohort study. Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed. Hospital eligibility: High volume centers (\> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome. Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017. Patient Exclusion criteria: detailed later. Data collection Deadline: 1st September 2017 - 30 April 2018

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 20, 2018
Enrollment StartOct 17, 2017
Primary CompletionSep 10, 2018
Study CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.4 years ago

Interventions

bariatric surgery (RYGB or SG)procedure

laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity