Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Procedure: sleeve gastrectomy; Procedure: one anastomosis gastric bypass

• Registration Number: NCT04134156
• Lead Sponsor: Mansoura University

Brief Summary

Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2018-12-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-22
• Last Update Posted: 2019-10-22
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients of both genders with morbid obesity (defined as BMI > 40 kg/m2 or > 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.

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Exclusion Criteria

• patients ageing more than 60 years
• patients with endocrine disorders
• patients with psychiatric disorders that influence perception of the study protocol
• patients unfit for general anesthesia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy	sleeve gastrectomy	5-port standard sleeve gastrectomy was conducted
one anastomosis gastric bypass	one anastomosis gastric bypass	5-port standard one-anastomosis gastric bypass was performed

Primary Outcome Measures

Name	Time	Method
excess weight loss	12 months after surgery	the percentage of excess weight loss after surgery

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt