Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2027-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases

NCT06598267

Bariatric Surgery

ACTIVE_NOT_RECRUITING NA

Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study

NCT01514799

Morbid Obesity Weight Loss

COMPLETED NA

Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

NCT05608772

Weight Loss Bariatric Surgery Candidate Comorbidities and Coexisting Conditions +1 more

RECRUITING NA

Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity

NCT05611697

Obesity, Morbid

RECRUITING NA

Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy For Morbidly Obese Patients

NCT04218045

Bariatric Surgery

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Morbid Metabolic Syndrome Bariatric Surgery Candidate Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SASI Bipartition

Subjects submitted to SASI Bipartition

SASI Bipartition

Intervention Type PROCEDURE

SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.

Roux-en-Y gastric bypass

Subjects submitted to gastric bypass

Gastric bypass

Intervention Type PROCEDURE

A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SASI Bipartition

SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.

Intervention Type PROCEDURE

Gastric bypass

A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Single-anastomosis Sleeve Ileal Bypass Roux-en-Y gastric bypass

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)