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Prospective Comparison Between SADI-S and Gastric Bypass

Non-randomized Prospective Comparison Between SADI-S and Gastric Bypass for the Treatment of Morbid Obesity and Its Associated Co-morbidities

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02768506
Acronym
SADI-S-GB
Enrollment
50
Registered
2016-05-11
Start date
2009-09-30
Completion date
2011-05-31
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Morbid Obesity

Keywords

obesity, malabsorption, gastric bypass, SADI-S

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.

Interventions

None listed

Sponsors

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Morbid obesity

Exclusion criteria

* Drug addiction * Alcoholic * Neoplasms * Immunosuppression * Mental diseases

Design outcomes

Primary

MeasureTime frameDescription
Weight loss5 yearsExcess weight loss percentage and total weight loss percentage in the first 5 years

Secondary

MeasureTime frameDescription
Diabetes remission5 yearsNormalization of glycemia and HbA1c with no anti-diabetic medications

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026