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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04037670
Other study ID # mansoura101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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