Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

Instituto Paulo Reis

Status and phase

Unknown

Phase 3

Conditions

Obesity

Treatments

Procedure: Scopinaro Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02373007

UTN U1111-1166-7218

Details and patient eligibility

About

The purpose of this study is to show that the modified technique Scopinaro surgery allows a better control or reduction of complications often found in nutritional pancreatic and biliary derivations, starting from the assumption of a modified technique is as effective as Scopinaro classical technique for reducing overweight and control of comorbidities in obese patients with grade II and III.

Full description

28 participants Will be recruited and will be divided into 2 groups of 14 subjects each one. One group will receive the Classic Scopinaro surgery and the other, Modified Scopinaro Surgery. In Scopinaro Surgery Modified will be held with laparotomy and median opening in layers. It will also be performed at the manufacturing drifting pancreatic and biliary derivations, Roux-en-Y, dividing the small stomach.A communication portal to be implemented and calibrated through a nasogastric tube of 10mm where a retaining ring is placed horizontal gastroplasty, in order to avoid an expansion of this communication.

In the Classical Scopinaro surgery will be done the same procedures of Scopinaro Modified surgery , but the gastroplasty will be replaced by horizontal gastrectomy.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) > 35;
Body Mass Index greater than or equal to 40;
Be indicated for bariatric surgery after other attempts at treatment;
If BMI > 35 and <40, must submit AT LEAST one of comorbidities below: Type II diabetes, dyslipidemia, hypertension, joint arthropathy in average or great, sleep apnea, hypothyroidism.

Exclusion criteria

Pregnant or breastfeeding
Had undergone bariatric surgery before.
Diagnostic of psychiatric disorders, according to the evaluation of especialist.
Be user of illegal drugs or alcohol abuse.
Be severe disease carrier, according to an evaluation specialist.
Have severe lung disease or liver cirrhosis, according to the evaluation of especialist.
Being active virus carrier - HIV.
Has any condition that prevents surgery