Back to resultsNaturally Banded Sleeve Gastrectomy
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LSG with omental band
LSG
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
- Minia university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LSG
LSG with omental band
Arm Description
just laparoscopic sleeve gastrectomy without banding
laparoscopic sleeve gastrectomy with omental banding
Outcomes
Primary Outcome Measures
the effect on weight loss
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
the size of gastric pouch at one year
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
Secondary Outcome Measures
the effect on comorbidities
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
operative time
operative time in minutes from skin incision to skin closure
the incidences of complications
the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05603338
Brief Title
Naturally Banded Sleeve Gastrectomy
Official Title
Naturally Banded Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)
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
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
Detailed Description
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LSG
Arm Type
Active Comparator
Arm Description
just laparoscopic sleeve gastrectomy without banding
Arm Title
LSG with omental band
Arm Type
Experimental
Arm Description
laparoscopic sleeve gastrectomy with omental banding
Intervention Type
Procedure
Intervention Name(s)
LSG with omental band
Intervention Description
LSG with omental band
Intervention Type
Procedure
Intervention Name(s)
LSG
Intervention Description
just to do sleeve gastrectomy
Primary Outcome Measure Information:
Title
the effect on 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
the size of gastric pouch at one year
Description
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the effect on comorbidities
Description
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
Time Frame
12 monthts
Title
operative time
Description
operative time in minutes from skin incision to skin closure
Time Frame
6 hours
Title
the incidences of complications
Description
the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy
Time Frame
12 monthss
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 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
Minia university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
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Naturally Banded Sleeve Gastrectomy
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