NCT03440138

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

February 7, 2018

Last Update Submit

September 18, 2019

Conditions

BenchmarkBariatric SurgeryRoux-en-y Gastric BypassSleeve GastrectomyComplications

Outcome Measures

Primary Outcomes (6)

  • Benchmark outcomes (best achievable outcomes after bariatric surgery)

    Comprehensive Complication Index (http://www.assessurgery.com/calculator\_single/)

    30 days postoperatively

  • Benchmark outcomes (best achievable outcomes after bariatric surgery)

    Comprehensive Complication Index (http://www.assessurgery.com/calculator\_single/)

    90 days postoperatively

  • Benchmark outcomes (best achievable outcomes after bariatric surgery)

    Comprehensive Complication Index (http://www.assessurgery.com/calculator\_single/)

    180 days postoperatively

  • Major complications after bariatric surgery

    Clavien-Dindo grade \> IIIa

    30 days postoperatively

  • Major complications after bariatric surgery

    Clavien-Dindo grade \> IIIa

    90 days postoperatively

  • Major complications after bariatric surgery

    Clavien-Dindo grade \> IIIa

    180 days postoperatively

Secondary Outcomes (4)

  • Case-mix within centers

    5 years

  • Excess weight loss after bariatric surgery

    1-year postoperatively

  • Excess weight loss after bariatric surgery

    3-years postoperatively

  • Excess weight loss after bariatric surgery

    5-years postoperatively

Study Arms (19)

University Hospital Zurich

Procedure: bariatric surgery (RYGB or SG)

St Pierre University Hospital, Brussels, Belgium

Procedure: bariatric surgery (RYGB or SG)

Sana Klinikum, Offenbach, Germany

Procedure: bariatric surgery (RYGB or SG)

Complutense University of Madrid, Spain

Procedure: bariatric surgery (RYGB or SG)

Musgrove Park Hospital, Taunton, UK

Procedure: bariatric surgery (RYGB or SG)

University of Gothenburg, Sweden

Procedure: bariatric surgery (RYGB or SG)

AZ Sint-Jan Hospital in Bruges, Belgium

Procedure: bariatric surgery (RYGB or SG)

Bristol

Procedure: bariatric surgery (RYGB or SG)

Cleveland Clinic, Weston, Florida, USA

Procedure: bariatric surgery (RYGB or SG)

Oswaldo Cruz German Hospital, Sao Paolo, Brazil

Procedure: bariatric surgery (RYGB or SG)

Clínica Las Condes, Santiago, Chile

Procedure: bariatric surgery (RYGB or SG)

Brown University, Providence Rhode Island

Procedure: bariatric surgery (RYGB or SG)

Fresno Bariatric, CA, USA

Procedure: bariatric surgery (RYGB or SG)

Rijnstate Hospital, Arnhem, The Netherlands

Procedure: bariatric surgery (RYGB or SG)

CHU Nice, France

Procedure: bariatric surgery (RYGB or SG)

Claraspital Basel, Switzerland

Procedure: bariatric surgery (RYGB or SG)

Gastro-Obeso-Center Advanced Med Inst, Brazil

Procedure: bariatric surgery (RYGB or SG)

Hospital Dipreca Santiago Región Metropolitana , Chile

Procedure: bariatric surgery (RYGB or SG)

Medical University Wien, Austria

Procedure: bariatric surgery (RYGB or SG)

Interventions

bariatric surgery (RYGB or SG)PROCEDURE

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

AZ Sint-Jan Hospital in Bruges, BelgiumBristolBrown University, Providence Rhode IslandCHU Nice, FranceClaraspital Basel, SwitzerlandCleveland Clinic, Weston, Florida, USAClínica Las Condes, Santiago, ChileComplutense University of Madrid, SpainFresno Bariatric, CA, USAGastro-Obeso-Center Advanced Med Inst, BrazilHospital Dipreca Santiago Región Metropolitana , ChileMedical University Wien, AustriaMusgrove Park Hospital, Taunton, UKOswaldo Cruz German Hospital, Sao Paolo, BrazilRijnstate Hospital, Arnhem, The NetherlandsSana Klinikum, Offenbach, GermanySt Pierre University Hospital, Brussels, BelgiumUniversity Hospital ZurichUniversity of Gothenburg, Sweden

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with severe obesity with a lower risk profile who undergo bariatric surgery

You may qualify if:

  • Adult patients of 18-65 years

You may not qualify if:

  • Maximum preoperative BMI of 50 kg/m2
  • Primary laparoscopic/robotic proximal Roux-en-Y gastric bypass or sleeve gastrectomy
  • Documented follow-up of at least 90 days
  • Open surgery
  • Previous intra-abdominal surgery (including previous bariatric surgery)
  • Pre-operative BMI over 50 kg/m2
  • Age over 65 years
  • Cardiovascular disease (e.g. cardiac arrhythmia, stroke, coronary artery disease) (Hypertension is allowed)
  • History of thromboembolic events and/or therapeutic anticoagulation
  • Diabetes mellitus (Type I and Type II, as defined by the American Diabetes Association)
  • Obstructive sleep apnea (recurrent episodes of upper airway collapse during sleep)
  • Chronic obstructive pulmonary disease (FEV1/FVC\<0.7)
  • Chronic kidney disease (eGFR \< 30ml/min/1.72 m2)
  • Inflammatory bowel disease (ulcerative colitis, Crohn's)
  • Immunosuppression therapy (e.g. steroids, calcineurin inhibitors, etc)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (5)

  • Rossler F, Sapisochin G, Song G, Lin YH, Simpson MA, Hasegawa K, Laurenzi A, Sanchez Cabus S, Nunez MI, Gatti A, Beltrame MC, Slankamenac K, Greig PD, Lee SG, Chen CL, Grant DR, Pomfret EA, Kokudo N, Cherqui D, Olthoff KM, Shaked A, Garcia-Valdecasas JC, Lerut J, Troisi RI, De Santibanes M, Petrowsky H, Puhan MA, Clavien PA. Defining Benchmarks for Major Liver Surgery: A multicenter Analysis of 5202 Living Liver Donors. Ann Surg. 2016 Sep;264(3):492-500. doi: 10.1097/SLA.0000000000001849.

    PMID: 27433909BACKGROUND

  • Muller X, Marcon F, Sapisochin G, Marquez M, Dondero F, Rayar M, Doyle MMB, Callans L, Li J, Nowak G, Allard MA, Jochmans I, Jacskon K, Beltrame MC, van Reeven M, Iesari S, Cucchetti A, Sharma H, Staiger RD, Raptis DA, Petrowsky H, de Oliveira M, Hernandez-Alejandro R, Pinna AD, Lerut J, Polak WG, de Santibanes E, de Santibanes M, Cameron AM, Pirenne J, Cherqui D, Adam RA, Ericzon BG, Nashan B, Olthoff K, Shaked A, Chapman WC, Boudjema K, Soubrane O, Paugam-Burtz C, Greig PD, Grant DR, Carvalheiro A, Muiesan P, Dutkowski P, Puhan M, Clavien PA. Defining Benchmarks in Liver Transplantation: A Multicenter Outcome Analysis Determining Best Achievable Results. Ann Surg. 2018 Mar;267(3):419-425. doi: 10.1097/SLA.0000000000002477.

    PMID: 28885508BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

    PMID: 23728278BACKGROUND

  • Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, Martin AS, Xiao Y, Galvao M, Giorgi M, Benois M, Espinoza F, Hollyman M, Lloyd A, Hosa H, Schmidt H, Garcia-Galocha JL, van de Vrande S, Chiappetta S, Menzo EL, Aboud CM, Luthy SG, Orchard P, Rothe S, Prager G, Pournaras DJ, Cohen R, Rosenthal R, Weiner R, Himpens J, Torres A, Higa K, Welbourn R, Berry M, Boza C, Iannelli A, Vithiananthan S, Ramos A, Olbers T, Sepulveda M, Hazebroek EJ, Dillemans B, Staiger RD, Puhan MA, Peterli R, Bueter M. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Ann Surg. 2019 Nov;270(5):859-867. doi: 10.1097/SLA.0000000000003512.

    PMID: 31592894DERIVED

Related Links

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med., PhD

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 20, 2018

Study Start

October 17, 2017

Primary Completion

September 10, 2018

Study Completion

September 17, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

the study is based on de-anonymised data, so it is impossible to backtrack it to a patient. only overall data will be shared, not individual data

Locations

CH(1)