Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Procedure: Gastric plication ileal bypass

• Registration Number: NCT03428386
• Lead Sponsor: Mansoura University

Brief Summary

The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Detailed Description

The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02-01
• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-08
• Last Update Submitted: 2018-02-08
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09
• Primary Completion: 2019-01-31
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study

Exclusion Criteria

• Patients with secondary obesity due to endocrine disorders
• patient unfit for general anesthesia.
• patients who had not attempted non-surgical weight loss treatment in the past
• patients with psychological conditions that influence his/her perception of the study protocol
• patients with previous surgery for morbid obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric plication ileal bypass	Gastric plication ileal bypass	single-anastomosis plication ileal bypass

Primary Outcome Measures

Name	Time	Method
weight loss	6 months	Percentage of excess weight loss at 6 months after the procedure

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt