Prospective Comparison Between SADI-S and Gastric Bypass (SADI-S-GB)

S

San Carlos Clinical Hospital

Status

Completed

Conditions

Diabetes
Morbid Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT02768506
ASP-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Morbid obesity

Exclusion criteria

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

Trial design

50 participants in 2 patient groups

Gastric bypass
Description:
Subjects submitted to gastric bypass
SADI-S
Description:
Subjects submitted to SADI-S

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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