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

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05590208
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.3
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid; GERD	Procedure: sleeve gastrectomy+ cruroplasty+ omental rap	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
• Actual Study Start Date: Oct 12, 2022
• Anticipated Primary Completion Date: Nov 20, 2023
• Anticipated Study Completion Date: Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sleeve gastrectomy+ cruroplasty + omental rape sleeve gastrectomy+ cruroplasty + omental rape	Procedure: sleeve gastrectomy+ cruroplasty+ omental rap; sleeve gastrectomy+ cruroplasty+ omental rap

Outcome Measures

Primary Outcome Measures

1. the effect on GERD [6 months]

   change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire

Secondary Outcome Measures

1. 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

2. comorbidities [12 months]

   change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia university hospital	Minya		Egypt	61511

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mstafa Hassan Sewefy, assistant professor of general surgery, Minia University
• ClinicalTrials.gov Identifier: NCT05590208
• Other Study ID Numbers: fac.med 22.64
• First Posted: Oct 21, 2022
• Last Update Posted: Oct 25, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Oct 25, 2022