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

Primary Purpose

Obesity, Morbid, GERD

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sleeve gastrectomy+ cruroplasty+ omental rap
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minia university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sleeve gastrectomy+ cruroplasty + omental rape

Arm Description

sleeve gastrectomy+ cruroplasty + omental rape

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 1, 2022
Last Updated
October 23, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05590208
Brief Title
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
Official Title
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. 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
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

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
sleeve gastrectomy+ cruroplasty + omental rape
Arm Type
Experimental
Arm Description
sleeve gastrectomy+ cruroplasty + omental rape
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy+ cruroplasty+ omental rap
Intervention Description
sleeve gastrectomy+ cruroplasty+ omental rap
Primary Outcome Measure Information:
Title
the effect on GERD
Description
change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
weight loss
Description
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
Time Frame
12 months
Title
comorbidities
Description
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alaa sewefy
Phone
+201006448805
Email
sewafy@yahoo.co.uk
Facility Information:
Facility Name
Minia university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy, MD
Phone
+201006448805
Email
sewafy@yahoo.co.uk

12. IPD Sharing Statement

Learn more about this trial

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

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