Single-Anastomosis Plication Ileal Bypass for Morbid Obesity
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 4, 2018
CompletedFirst Posted
Study publicly available on registry
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedFebruary 9, 2018
February 1, 2018
12 months
February 4, 2018
February 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
weight loss
Percentage of excess weight loss at 6 months after the procedure
6 months
Study Arms (1)
Gastric plication ileal bypass
EXPERIMENTALsingle-anastomosis plication ileal bypass
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D.
Mansoura University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
February 4, 2018
First Posted
February 9, 2018
Study Start
February 1, 2018
Primary Completion
January 31, 2019
Study Completion
May 30, 2019
Last Updated
February 9, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share