Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428386
• Other study ID #: mansourau46
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2018
• Last updated: February 8, 2018
• Start date: February 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2018
• Source: Mansoura University
• Contact: Sameh H Emile, M.D.
• Phone: +201006267150
• Email: sameh200[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Gastric plication ileal bypass
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

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Percentage of excess weight loss at 6 months after the procedure	6 months