Back to resultsLaparoscopic Natural Gastric Banding for Morbid Obesity
Primary Purpose
Obesity, Morbid
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gastric band
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid
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 previous restrictive bariatric procedure Exclusion Criteria: 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
Sites / Locations
- Faculty of medicineRecruiting
- Minia university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
gastric band
sleeve gastrectomy
Arm Description
to do gastric banding use either round ligament or omental flap
to do sleeve gastrectomy as standard
Outcomes
Primary Outcome Measures
%EWL
percentage of excess weight loss at one year
Secondary Outcome Measures
complications rate
the incidence of complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05912920
Brief Title
Laparoscopic Natural Gastric Banding for Morbid Obesity
Official Title
Laparoscopic Natural Gastric Banding for Management of Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (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
to do gastric banding using round ligament or omental flap instead of synesthetic band
Detailed Description
the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gastric band
Arm Type
Experimental
Arm Description
to do gastric banding use either round ligament or omental flap
Arm Title
sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
to do sleeve gastrectomy as standard
Intervention Type
Procedure
Intervention Name(s)
gastric band
Intervention Description
gastric band
Primary Outcome Measure Information:
Title
%EWL
Description
percentage of excess weight loss at one year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
complications rate
Description
the incidence of complications
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
18 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
previous restrictive bariatric procedure
Exclusion Criteria:
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
Facility Information:
Facility Name
Faculty of medicine
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
First Name & Middle Initial & Last Name & Degree
M
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
Laparoscopic Natural Gastric Banding for Morbid Obesity
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