Overview

This trial is active, not recruiting.

Condition obesity
Treatment scopinaro surgery
Phase phase 3
Sponsor Instituto Paulo Reis
Start date July 2014
End date December 2015
Trial size 28 participants
Trial identifier NCT02373007, UTN U1111-1166-7218

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
Patients will get the Bariatric surgery using the Classic Scopinaro Techniques
scopinaro surgery
Classic Scopinaro Technique is a bariactric surgery that proposes the stomach will be divide in two parts: a proximal part and a distal part for performing horizontal gastrectomy. Differently what will happen in the Modified Scopinaro Surgery that will divide the stomach in two parts: a proximal part and a distal part for performing gastroplasty.
(Other)
Patients will get Bariatric surgery using the Modified Scopinaro Techniques
scopinaro surgery
Classic Scopinaro Technique is a bariactric surgery that proposes the stomach will be divide in two parts: a proximal part and a distal part for performing horizontal gastrectomy. Differently what will happen in the Modified Scopinaro Surgery that will divide the stomach in two parts: a proximal part and a distal part for performing gastroplasty.

Primary Outcomes

Measure
Number of patients with adverse events
time frame: 18 months after the surgery.

Secondary Outcomes

Measure
Number of patients that regain weight
time frame: 18 months after the surgery.
deaths
time frame: 18 months from the surgery

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Evaluation of Safety and Effectiveness Modified Scopinaro Technique in the Surgical Treatment of Obesity Compared to Classical Scopinaro Technique
Principal investigator Paulo R Esselin de Melo
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Instituto Paulo Reis.