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Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

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ClinicalTrials.gov Identifier: NCT03428386
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Gastric plication ileal bypass Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : May 30, 2019

Arm Intervention/treatment
Experimental: Gastric plication ileal bypass
single-anastomosis plication ileal bypass
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




Primary Outcome Measures :
  1. weight loss [ Time Frame: 6 months ]
    Percentage of excess weight loss at 6 months after the procedure



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428386


Contacts
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Contact: Sameh H Emile, M.D. +201006267150 sameh200@hotmail.com
Contact: Sameh H Emile sameh200@hotmail.com

Locations
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Egypt
Mansoura university hospital Recruiting
Mansourah, Dakahlia, Egypt
Contact: Sameh Emile, M.D       sameh200@hotmail.com   
Contact: Sameh H Emile, M.D.         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh H Emile, M.D. Mansoura University Hospital

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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03428386     History of Changes
Other Study ID Numbers: mansourau46
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms