Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease

Not Applicable

Completed

• Conditions: GERD; Obesity, Morbid
• Interventions: Procedure: sleeve gastrectomy+ cruroplasty+ omental rap

• Registration Number: NCT05590208
• Lead Sponsor: Minia University

Brief Summary

in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

Detailed Description

in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction

Study Timeline

• Study First Submitted: 2022-10-01
• Study Start: 2022-10-12
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Status Verified: 2022-12
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Last Update Submitted: 2024-01-13
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
• patients fit for laparoscopic surgery
• give approval to share in the study

Exclusion Criteria

• patients refused to share in the study
• patients unfit for surgery
• patients aged less than 18 and older than 60
• patient with previous upper abdominal surgery either for obesity or other diseases
• revisional bariatric procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sleeve gastrectomy+ cruroplasty + omental rape	sleeve gastrectomy+ cruroplasty+ omental rap	sleeve gastrectomy+ cruroplasty + omental rape

Primary Outcome Measures

Name	Time	Method
the effect on GERD	6 months	change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire

Secondary Outcome Measures

Name	Time	Method
weight loss	12 months	the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
comorbidities	12 months	change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

Trial Locations

Locations (1)

Minia university hospital; 🇪🇬 Minya, Egypt