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Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gastric plication ileal bypass
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Mansoura university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric plication ileal bypass

Arm Description

single-anastomosis plication ileal bypass

Outcomes

Primary Outcome Measures

weight loss
Percentage of excess weight loss at 6 months after the procedure

Secondary Outcome Measures

Full Information

First Posted
February 4, 2018
Last Updated
February 8, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03428386
Brief Title
Single-Anastomosis Plication Ileal Bypass for Morbid Obesity
Official Title
Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric plication ileal bypass
Arm Type
Experimental
Arm Description
single-anastomosis plication ileal bypass
Intervention Type
Procedure
Intervention Name(s)
Gastric plication ileal bypass
Intervention Description
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 Measure Information:
Title
weight loss
Description
Percentage of excess weight loss at 6 months after the procedure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile, M.D.
Phone
+201006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile
Email
sameh200@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

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