Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

Mansoura University

Status: Unknown

Conditions: Morbid Obesity

Treatments: Procedure: Gastric plication ileal bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03428386

mansourau46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Gastric plication ileal bypass

Experimental group

Description:

single-anastomosis plication ileal bypass

Treatment:

Procedure: Gastric plication ileal bypass