Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

  • STATUS
    Recruiting
  • End date
    Aug 5, 2027
  • participants needed
    280
  • sponsor
    Aleris Hospital
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Updated on 16 February 2024
See if I qualify
hypertension
dyslipidemia
sleep apnea
arthritis
apnea
postoperative complications
type 2 diabetes
bariatric surgery
gastric bypass
morbid obesity
diabetes
type 2 diabetes mellitus

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 Morbid obesity, Metabolic disorder, Postoperative Complication, Metabolic syndrome, Metabolic syndrome, Bariatric Surgery Candidate
Age 18years - 70years
Treatment SASI Bipartition, Gastric bypass
Clinical Study IdentifierNCT04469712
SponsorAleris Hospital
Last Modified on16 February 2024

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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hypertension
dyslipidemia
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arthritis
apnea
postoperative complications
type 2 diabetes
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gastric bypass
morbid obesity
diabetes
type 2 diabetes mellitus

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