NCT00356213

Brief Summary

The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients. In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG) leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus (PGB).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2006

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

10.8 years

First QC Date

July 24, 2006

Last Update Submit

September 13, 2017

Conditions

Morbid Obesity

Keywords

morbid obesitybariatric surgerysleeve-gastrectomyRoux-Y-gastric bypassoutcomeweight loss

Outcome Measures

Primary Outcomes (1)

  • effectiveness in terms of weight loss, reduction in co-morbidity and quality of life

    5 years

Secondary Outcomes (1)

  • early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.

    5 years

Study Arms (2)

A

EXPERIMENTAL

laparoscopic sleeve gastrectomy

Procedure: sleeve gastrectomy

B

ACTIVE COMPARATOR

laparoscopic gastric bypass

Procedure: Roux-Y-gastric bypass

Interventions

sleeve gastrectomyPROCEDURE

laparoscopic sleeve gastrectomy

Also known as: bariatric operation
A
Roux-Y-gastric bypassPROCEDURE

laparoscopic gastric bypass

Also known as: bariatric operation
B

Eligibility Criteria

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

You may qualify if:

  • BMI\>40

You may not qualify if:

  • contraindication for bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kraljevic M, Susstrunk J, Wolnerhanssen BK, Peters T, Bueter M, Gero D, Schultes B, Poljo A, Schneider R, Peterli R. Long-Term Outcomes of Laparoscopic Roux-en-Y Gastric Bypass vs Laparoscopic Sleeve Gastrectomy for Obesity: The SM-BOSS Randomized Clinical Trial. JAMA Surg. 2025 Apr 1;160(4):369-377. doi: 10.1001/jamasurg.2024.7052.

    PMID: 39969869DERIVED

  • Peterli R, Hurme S, Bueter M, Gronroos S, Helmio M, Salminen P. Standardized Assessment of Metabolic Bariatric Surgery Outcomes: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Surg. 2024 Mar 1;159(3):306-314. doi: 10.1001/jamasurg.2023.6254.

    PMID: 38055284DERIVED

  • Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.

    PMID: 37652841DERIVED

  • Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.

    PMID: 29340679DERIVED

  • Peterli R, Steinert RE, Woelnerhanssen B, Peters T, Christoffel-Courtin C, Gass M, Kern B, von Fluee M, Beglinger C. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012 May;22(5):740-8. doi: 10.1007/s11695-012-0622-3.

    PMID: 22354457DERIVED

  • Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3.

    PMID: 19638921DERIVED

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Ralph Peterli, Dr.

    Leitender Arzt, Allgemeinchirurgische Abteilung, St.Claraspital, CH-4016 Basel

    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

July 24, 2006

First Posted

July 25, 2006

Study Start

October 30, 2006

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09