Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sleeve gastrectomy

5-port standard sleeve gastrectomy was conducted

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

5-port sleeve gastrectomy

one anastomosis gastric bypass

5-port standard one-anastomosis gastric bypass was performed

Group Type ACTIVE_COMPARATOR

one anastomosis gastric bypass

Intervention Type PROCEDURE

5-port one anastomosis gastric bypass

Interventions

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sleeve gastrectomy

5-port sleeve gastrectomy

Intervention Type PROCEDURE

one anastomosis gastric bypass

5-port one anastomosis gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No