Prospective Comparison Between SADI-S and Gastric Bypass

NCT ID: NCT02768506

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Morbid Obesity Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric bypass

Subjects submitted to gastric bypass

No interventions assigned to this group

SADI-S

Subjects submitted to SADI-S

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Morbid obesity

Exclusion Criteria

* Drug addiction
* Alcoholic
* Neoplasms
* Immunosuppression
* Mental diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Andres Sanchez-Pernaute

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital ClĂ­nico San Carlos

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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ASP-004

Identifier Type: -

Identifier Source: org_study_id

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