Efficacy of SASI Bypass in Super Obese Patients

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: SASI bypass

• Registration Number: NCT04037670
• Lead Sponsor: Mansoura University

Brief Summary

Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-07-20
• Status Verified: 2019-07
• Study Completion: 2019-07-20
• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-28
• Last Update Submitted: 2019-07-28
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).

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Exclusion Criteria

• Pregnant women.
• Patients unfit for general anasthesia (ASA 4, 5)
• Endocrine or psychiatric disorders.
• History of previous upper abdmominal laparotomy.
• Alcoholic addiction
• Liver cirrhosis
• Coagulopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SASI bypass	SASI bypass	Patients with super obesity underwent SASI bypass

Primary Outcome Measures

Name	Time	Method
percentage of excess weight loss	at 12 months of follow-up	\[preoperative weight - weight at 12 months\]/preoperative excess weight X 100

Secondary Outcome Measures

Name	Time	Method
Resolution of diabetes mellitus	at 12 months of follow-up	number of patients with fasting plasma glucose level \<110 mg/dL or HbA1C level \<6% without hypoglycemic medication

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt