Non-randomized Prospective Comparison Between SASI Bipartition and RYGB
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- STATUS
- Recruiting
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- End date
- Aug 5, 2027
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- participants needed
- 280
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- sponsor
- Aleris Hospital
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 Identifier | NCT04469712 |
| Sponsor | Aleris Hospital |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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