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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
Sponsor:
Information provided by (Responsible Party):
Alaa Mstafa Hassan Sewefy, Minia University

Study Description
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Brief Summary:
150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass with biliary limb length of 200 cm from the duodenal-jejunal flexure 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: SAS-JB Procedure: MBG Procedure: LSG Not Applicable

Detailed Description:
150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass with biliary limb length of 200 cm from the duodenal-jejunal flexure 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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: SAS-JB
laparoscopic single anastomosis sleeve jejunal bypass
 Procedure: SAS-JB
Active Comparator: MGB
laparoscopic mini gastric bypass
 Procedure: MBG
Active Comparator: LSG
laparoscopic sleeve gastrectomy
 Procedure: LSG


Outcome Measures
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Primary Outcome Measures :
  1. percentage of excess weight loss [ Time Frame: 12 months ]
    percentage of excess weight loss in kilogram


Secondary Outcome Measures :
  1. the incidence of nutritional deficiency [ Time Frame: 2 years ]
    the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.

  2. the rate of improved co morbidity [ Time Frame: 2 years ]
    the effect of the operation on co morbidity like diabetes and hypertension

  3. the incidence of early operative complications [ Time Frame: one month ]
    early operative complications like leak, bleeding


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Egypt
Faculty of medicine
Minya, Egypt, 61511
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Alaa M Sewefy, MD Minia University
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight