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OpenTrials
Completed

NCT Number: NCT02768506

Prospective Comparison Between SADI-S and Gastric Bypass

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.

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Key information

Conditions

Morbid Obesity Body Weight Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Morbid obesity

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Weight loss

    Time frame: 5 years

    Excess weight loss percentage and total weight loss percentage in the first 5 years

Secondary outcomes

  1. Diabetes remission

    Time frame: 5 years

    Normalization of glycemia and HbA1c with no anti-diabetic medications

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

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

Acronym: SADI-S-GB

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 11, 2016
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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