Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

A

Aleris Hospital

Status

Active, not recruiting

Conditions

Postoperative Complications
Bariatric Surgery Candidate
Metabolic Syndrome
Obesity, Morbid

Treatments

Procedure: SASI Bipartition
Procedure: Gastric bypass

Study type

Observational

Funder types

Other

Identifiers

NCT04469712
66095

Details and patient eligibility

About

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

Full 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.

Enrollment

280 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

280 participants in 2 patient groups

SASI Bipartition
Description:
Subjects submitted to SASI Bipartition
Treatment:
Procedure: SASI Bipartition
Roux-en-Y gastric bypass
Description:
Subjects submitted to gastric bypass
Treatment:
Procedure: Gastric bypass

Trial contacts and locations

1

Loading...

Central trial contact

Ebrahim Aghajani, PhD; Carl Fredrik Schou, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems