Prospective Comparison Between SADI-S and Gastric Bypass

Completed

• Conditions: Morbid Obesity; Diabetes

• Registration Number: NCT02768506
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a variable limb length between 250 cm and 300 cm or gastric bypass.

Results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

Detailed Description

Morbid obese patients and patients with an initial BMI over 35 with associated comorbidities - as diabetes mellitus - are evaluated for bariatric surgery. Candidates are offered a standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy. Patients with higher BMI and those with worse metabolic condition are encouraged to accept the malabsorptive option.

Gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and anastomosis over a 14 mm bougie. SADI-S is performed with a sleeve gastrectomy over a 54 French (18 mm) gastric bougie and a 250 cm common limb.

Patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to remove abdominal drain and 3 days to discharge unless contraindicated. Follow up is performed through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd to the 5th year.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-08
• Last Update Submitted: 2016-05-08
• Study First Posted: 2016-05-11
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Morbid obesity

Exclusion Criteria

• Drug addiction
• Alcoholic
• Neoplasms
• Immunosuppression
• Mental diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss	5 years	Excess weight loss percentage and total weight loss percentage in the first 5 years

Secondary Outcome Measures

Name	Time	Method
Diabetes remission	5 years	Normalization of glycemia and HbA1c with no anti-diabetic medications

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain