Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Gastric plication ileal bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric plication ileal bypass<br>single-anastomosis plication ileal bypass | Procedure: Gastric plication ileal bypass<br>* laparoscopic plication of the greater curvature of the stomach then the duodeno-jejunal junction is identified and 300 cm is measured downwards. The selected loop will be ascended without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just 3 cm away from the pylorus with a linear stapler charged with a green cartridge, the diameter of ileal antrum anastomosis is not exceeding 3 cm in diameter. The staple defect is closed with a two-layer running 3/0 polyglactin suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | Percentage of excess weight loss at 6 months after the procedure | 6 months |