Clinical trial

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04469712

Active, not recruitingNot applicableObservational

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid, Metabolic Syndrome, Bariatric Surgery Candidate, Postoperative Complications

Full registry criteria

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

Treatments and study arms

SASI Bipartition

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.

Gastric bypass

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.

Primary outcomes

Weight change3 to 60 months after surgery

Measured as percent of Excess Weight Loss (%EWL) using the following formula: ((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100

Waist size change3 to 60 months after surgery

Waist size (in cm)

Medical and surgical complication3 to 60 months after surgery

According to Clavien-Dindo classification

Operative timeDuring surgery

Expressed in minutes

Hemoglobinbefore surgery up to 60 months after surgery

Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l

Albuminbefore surgery up to 60 months after surgery

Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l

Ferritinbefore surgery up to 60 months after surgery

Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l

Ironbefore surgery up to 60 months after surgery

Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Aleris Hospital🇳🇴 Oslo, Norway

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