Obesity, Morbid
Conditions
Brief summary
to compare the results of SASI to SAS-J in treatment of morbid obesity
Detailed description
200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J
Interventions
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nutritional deficiency | 12 months | the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comorbidities | 1 year | change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer |
| complications | 1 year | early and late complications |
| weight loss | 12 months | the effect of the 2 procedures on weight measured by percentage of excess weight loss |
Countries
Egypt
Outcome results
None listed