Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
NCT ID: NCT00356213
Last Updated: 2017-09-14
Study Results
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Basic Information
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COMPLETED
NA
217 participants
INTERVENTIONAL
2006-10-30
2017-08-31
Brief Summary
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Detailed Description
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Obesity is reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and cure of comorbidities in the majority of patients. There exist a number of different operations resulting in either a restrictive effect and/or malabsorption, accompanied by a humoral effect which is caused by changes of the different gastrointestinal hormones. It is still unknown which patients needs which operation.
Working Hypothesis
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).
Specific Aims
We plan to compare the SG and PGB in a prospective randomized study. Primary outcome measure is effectiveness in terms of weight loss, reduction in co-morbidity and quality of life, secondary outcome measures are early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.
Experimental Design/Methods
An interdisciplinary team evaluates morbidly obese patients for bariatric surgery. After informed consent eligible patients will be randomized into SG or PGB, a number of 45 per group. Preoperative examination consists of: quantification of comorbidity, eating behavior, indirect calorimetry, body composition by dual energy x-ray absorptiometry (DEXA), routine blood chemistry, gastrointestinal hormones before and after test meal, gastroscopy, manometry of the esophagus, upper GI series, abdominal ultrasound, quality of life. Perioperative investigations: operative time, fat tissue samples (omental and subcutaneous), early morbidity, gastrointestinal hormones before and after test meal, duration of hospital stay, costs; Follow-up data will be obtained every 3 months in the first year, twice in the second year and once per year thereafter: weight, reduction in comorbidities, blood tests, gastrointestinal hormones before and after test meal, DEXA and quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
laparoscopic sleeve gastrectomy
sleeve gastrectomy
laparoscopic sleeve gastrectomy
B
laparoscopic gastric bypass
Roux-Y-gastric bypass
laparoscopic gastric bypass
Interventions
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sleeve gastrectomy
laparoscopic sleeve gastrectomy
Roux-Y-gastric bypass
laparoscopic gastric bypass
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Ethicon Endo-Surgery
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Ralph Peterli, Dr.
Role: PRINCIPAL_INVESTIGATOR
Leitender Arzt, Allgemeinchirurgische Abteilung, St.Claraspital, CH-4016 Basel
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Peterli1
Identifier Type: -
Identifier Source: org_study_id
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