Efficacy of SASI Bypass in Super Obese Patients

Morbid Obesity Clinical Trial

Official title:

Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037670
• Other study ID #: mansoura101
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• SASI bypass
Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of excess weight loss	[preoperative weight - weight at 12 months]/preoperative excess weight X 100	at 12 months of follow-up
Secondary	Resolution of diabetes mellitus	number of patients with fasting plasma glucose level <110 mg/dL or HbA1C level <6% without hypoglycemic medication	at 12 months of follow-up