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NCT03440138: BBenchmarks

Defining Benchmarks in Bariatric Surgery

Completed Last updated 19 September 2019
What this trial tests

trial testing bariatric surgery (RYGB or SG) in Benchmark in 5,741 participants. Completed in 17 September 2019.

Timeline
17 October 2017
Primary endpoint
10 September 2018
17 September 2019

Quick facts

Lead sponsorMarco Bueter
StatusCompleted
Study typeOBSERVATIONAL
Enrollment5,741
Start date17 October 2017
Primary completion10 September 2018
Estimated completion17 September 2019
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Marco Bueter

Who can join

Adults 18 to 65, any sex, with Benchmark or Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.
    Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, et al · · 2019 · cited 94× · PMID 31592894 · DOI 10.1097/sla.0000000000003512

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Other recruiting trials for Benchmark

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03440138.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing