Back to resultsEfficacy of SASI Bypass in Super Obese Patients
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SASI bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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).
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
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SASI bypass
Arm Description
Patients with super obesity underwent SASI bypass
Outcomes
Primary Outcome Measures
percentage of excess weight loss
[preoperative weight - weight at 12 months]/preoperative excess weight X 100
Secondary Outcome Measures
Resolution of diabetes mellitus
number of patients with fasting plasma glucose level <110 mg/dL or HbA1C level <6% without hypoglycemic medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04037670
Brief Title
Efficacy of SASI Bypass in Super Obese Patients
Official Title
Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SASI bypass
Arm Type
Experimental
Arm Description
Patients with super obesity underwent SASI bypass
Intervention Type
Procedure
Intervention Name(s)
SASI bypass
Intervention Description
Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction
Primary Outcome Measure Information:
Title
percentage of excess weight loss
Description
[preoperative weight - weight at 12 months]/preoperative excess weight X 100
Time Frame
at 12 months of follow-up
Secondary Outcome Measure Information:
Title
Resolution of diabetes mellitus
Description
number of patients with fasting plasma glucose level <110 mg/dL or HbA1C level <6% without hypoglycemic medication
Time Frame
at 12 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of SASI Bypass in Super Obese Patients
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