Morbid Obesity Clinical Trial
Official title:
Single Anastomosis Sleeve Jejunal Bypass Compared to One Anastomosis Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity
| Verified date | December 2021 |
| Source | Minia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | August 10, 2020 |
| Est. primary completion date | August 10, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of medicine | Minya |
| Lead Sponsor | Collaborator |
|---|---|
| Minia University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | percentage of excess weight loss | percentage of excess weight loss in kilogram | 12 months | |
| Secondary | the incidence of nutritional deficiency | the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia. | 2 years | |
| Secondary | the rate of improved co morbidity | the effect of the operation on co morbidity like diabetes and hypertension | 2 years | |
| Secondary | the incidence of early operative complications | early operative complications like leak, bleeding | one month |
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