Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

  • STATUS
    Recruiting
  • End date
    Aug 25, 2027
  • participants needed
    280
  • sponsor
    Aleris Hospital
Updated on 25 March 2022
diabetes
hypertension
type 2 diabetes mellitus
apnea
dyslipidemia
gastric bypass
morbid obesity

Summary

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

Description

The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary.

Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery.

Results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Details
Condition Obesity, Morbid, Metabolic Syndrome, Bariatric Surgery Candidate, Postoperative Complications
Treatment Gastric bypass, SASI Bipartition
Clinical Study IdentifierNCT04469712
SponsorAleris Hospital
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)

Exclusion Criteria

Mental diseases
Drug addiction
Alcoholic
Malignancy
Pregnancy
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