Obesity, Morbid
Conditions
Brief summary
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)
Detailed description
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost
Interventions
PROCEDUREnatural band
to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
PROCEDUREsilicone band
to use synesthetic band with sleeve gastrectomy
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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
Exclusion criteria
* patients refused to share in the study * patients unfit for surgery * patients aged less than 18 and older than 65 * patient with previous upper abdominal surgery either for obesity or other diseases * revisional bariatric procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total cost | 12 hours | total operative cost in Egyptian pound (LE) |
| food intolerance | 1 year | food intolerance at one year food tolerance arabic score questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| %EWL | 1 year | percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100 |
| complications rate | 1 year | the incidence of early and late complications according to Clavien-Dindo (CD) |
| improvement of comorbidities | 1 year | the incidence of improvement of comorbidities |
Outcome results
None listed