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Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sleeve gastrectomy
one anastomosis gastric bypass
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sleeve gastrectomy

one anastomosis gastric bypass

Arm Description

5-port standard sleeve gastrectomy was conducted

5-port standard one-anastomosis gastric bypass was performed

Outcomes

Primary Outcome Measures

excess weight loss
the percentage of excess weight loss after surgery

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
October 18, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04134156
Brief Title
Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial
Official Title
Weight Loss and Change in Ghrelin and GLP-1 Levels After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
5-port standard sleeve gastrectomy was conducted
Arm Title
one anastomosis gastric bypass
Arm Type
Active Comparator
Arm Description
5-port standard one-anastomosis gastric bypass was performed
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
5-port sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
one anastomosis gastric bypass
Intervention Description
5-port one anastomosis gastric bypass
Primary Outcome Measure Information:
Title
excess weight loss
Description
the percentage of excess weight loss after surgery
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

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