Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

NCT02373007 | Unknown Phase 3

• 1 other identifier: UTN U1111-1166-7218
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  Patients will be followed for 18 months after surgery and will follow-up visits to collect information about body weight, complications from surgery, liver diseases, nutritional status, adverse events and evaluation of quality of life

  18 months after the surgery.

Secondary Outcomes (2)

• Number of patients that regain weight

  18 months after the surgery.

• deaths

  18 months from the surgery

Study Arms (2)

Classic Scopinaro Surgery

OTHER

Patients will get the Bariatric surgery using the Classic Scopinaro Techniques

Procedure: Scopinaro Surgery

Modified Scopinaro Surgery

OTHER

Patients will get Bariatric surgery using the Modified Scopinaro Techniques

Procedure: Scopinaro Surgery

Interventions

Scopinaro Surgery PROCEDURE

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.

Classic Scopinaro Surgery; Modified Scopinaro Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Paulo Reis: lead

Study Sites (1)

Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S

Goiânia, Goiás, 74125-070, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo R Esselin de Melo

  INSTITUTO PAULO REIS DE CLINICA CIRURGICA E OBESIDADE MORBIDA S/S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paulo Reis Esselin de Melo

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 26, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

BR (1)