Single Anastomosis Sleeve Jejunal Bypass Compared to Mini Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity
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ClinicalTrials.gov Identifier: NCT03821688 |
Recruitment Status :
Completed
First Posted : January 30, 2019
Last Update Posted : March 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Morbid Obesity | Procedure: SAS-JB Procedure: MBG Procedure: LSG | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Single Anastomosis Sleeve Jejunal Bypass |
Actual Study Start Date : | May 15, 2016 |
Actual Primary Completion Date : | August 10, 2018 |
Actual Study Completion Date : | August 10, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: SAS-JB
laparoscopic single anastomosis sleeve jejunal bypass
|
Procedure: SAS-JB |
Active Comparator: MGB
laparoscopic mini gastric bypass
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Procedure: MBG |
Active Comparator: LSG
laparoscopic sleeve gastrectomy
|
Procedure: LSG |
- percentage of excess weight loss [ Time Frame: 12 months ]percentage of excess weight loss in kilogram
- the incidence of nutritional deficiency [ Time Frame: 2 years ]the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
- the rate of improved co morbidity [ Time Frame: 2 years ]the effect of the operation on co morbidity like diabetes and hypertension
- the incidence of early operative complications [ Time Frame: one month ]early operative complications like leak, bleeding

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821688
Egypt | |
Faculty of medicine | |
Minya, Egypt, 61511 |
Principal Investigator: | Alaa M Sewefy, MD | Minia University |
Responsible Party: | Alaa Mstafa Hassan Sewefy, Assistant professor, Minia University |
ClinicalTrials.gov Identifier: | NCT03821688 |
Other Study ID Numbers: |
fac.med.047 |
First Posted: | January 30, 2019 Key Record Dates |
Last Update Posted: | March 17, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Obesity, Morbid Overnutrition |
Nutrition Disorders Overweight Body Weight |