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Defining Benchmarks in Bariatric Surgery

NCT03440138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5741

Last updated 2019-09-19

No results posted yet for this study

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

Conditions

  • Benchmark
  • Bariatric Surgery
  • Roux-en-y Gastric Bypass
  • Sleeve Gastrectomy
  • Complications

Interventions

PROCEDURE

bariatric surgery (RYGB or SG)

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

Sponsors & Collaborators

  • Dr. med. Daniel Gero

    collaborator UNKNOWN

  • Dr. med. Dimitri A. Raptis, PhD

    collaborator UNKNOWN

  • Dr. med. Henner Schmidt

    collaborator UNKNOWN

  • Marco Bueter

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2018-09-10
Completion
2019-09-17

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440138 on ClinicalTrials.gov