NCT02475590

Brief Summary

Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

6.3 years

First QC Date

May 26, 2015

Last Update Submit

February 27, 2018

Conditions

Morbid Obesity

Keywords

Sleeve gastrectomyRoux-en-Y gastric bypassExcess weight lossQuality of life

Outcome Measures

Primary Outcomes (2)

  • Excess weight loss at 3 years

    % of excess weight loss

    At 36 months

  • Change in excess weight loss

    % of excess weight loss

    At 1, 3, 6, 12, months and every year for 10 years

Secondary Outcomes (13)

  • Nutritional status and vitamin deficiency

    At 1, 3, 6, 12, 18, 24, 30 and 36 months

  • Nutritional status and vitamin deficiency

    At 1, 3, 6, 12, 18, 24, 30 and 36 months

  • Nutritional status and vitamin deficiency

    At 1, 3, 6, 12, 18, 24, 30 and 36 months

  • Nutritional status and vitamin deficiency

    At 1, 3, 6, 12, 18, 24, 30 and 36 months

  • Nutritional status and vitamin deficiency

    At 1, 3, 6, 12, 18, 24, 30 and 36 months

  • +8 more secondary outcomes

Study Arms (2)

Sleeve gastrectomy

EXPERIMENTAL

Laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

Roux-en-Y gastric bypass

EXPERIMENTAL

Laparoscopic Roux-en-Y gastric bypass

Procedure: Laparoscopic Roux-en-Y gastric bypass

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Laparoscopic sleeve gastrectomy

Sleeve gastrectomy
Laparoscopic Roux-en-Y gastric bypassPROCEDURE

Laparoscopic Roux-en-Y gastric bypass

Roux-en-Y gastric bypass

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>40 and \< 60 kg/m2
  • No contraindication to any of the procedures
  • No contraindication to general anesthesia
  • No known addiction
  • Patient able to provide informed consent

You may not qualify if:

  • Contraindication to general anesthesia
  • Known psychiatric pathology
  • Pregnancy
  • Previous major digestive surgery
  • Immunosuppressive treatment including corticoids
  • Coagulopathy (INR\>1.5) or platelets \< 50 000/µl
  • Anemia (Hb\<10g/dl)
  • Severe comorbidity
  • Malabsorptive disease or gastro-intestinal disease
  • Myocardial infarction in previous year, angina, cardiac failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, 67 000, France

Location

Related Publications (3)

  • Vix M, Liu KH, Diana M, D'Urso A, Mutter D, Marescaux J. Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial. Surg Endosc. 2014 Mar;28(3):821-6. doi: 10.1007/s00464-013-3276-x. Epub 2013 Nov 7.

    PMID: 24196556BACKGROUND

  • Vix M, Diana M, Liu KH, D'Urso A, Mutter D, Wu HS, Marescaux J. Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial. Obes Surg. 2013 May;23(5):613-21. doi: 10.1007/s11695-012-0827-5.

    PMID: 23207829BACKGROUND

  • Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.

    PMID: 27901287DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacques Marescaux, MD

    Strasbourg university hospital, IRCAD, IHU Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 18, 2015

Study Start

March 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2022

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

FR(1)