Obesity, Morbid
Conditions
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
Interventions
PROCEDURELSG with omental band
LSG with omental band
PROCEDURELSG
just to do sleeve gastrectomy
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the effect on 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 |
| the size of gastric pouch at one year | 12 months | the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the effect on comorbidities | 12 monthts | change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer |
| operative time | 6 hours | operative time in minutes from skin incision to skin closure |
| the incidences of complications | 12 monthss | 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 |
Countries
Egypt
Outcome results
None listed