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Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Scopinaro Surgery
Sponsored by
Instituto Paulo Reis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Classic Scopinaro Surgery

Modified Scopinaro Surgery

Arm Description

Patients will get the Bariatric surgery using the Classic Scopinaro Techniques

Patients will get Bariatric surgery using the Modified Scopinaro Techniques

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients that regain weight
Patients will be followed for 18 months after surgery and will follow-up visits to collect information about body weight.
deaths
Number of patients that died

Full Information

First Posted
February 5, 2015
Last Updated
April 26, 2016
Sponsor
Instituto Paulo Reis
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1. Study Identification

Unique Protocol Identification Number
NCT02373007
Brief Title
Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity
Official Title
Evaluation of Safety and Effectiveness Modified Scopinaro Technique in the Surgical Treatment of Obesity Compared to Classical Scopinaro Technique
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Paulo Reis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classic Scopinaro Surgery
Arm Type
Other
Arm Description
Patients will get the Bariatric surgery using the Classic Scopinaro Techniques
Arm Title
Modified Scopinaro Surgery
Arm Type
Other
Arm Description
Patients will get Bariatric surgery using the Modified Scopinaro Techniques
Intervention Type
Procedure
Intervention Name(s)
Scopinaro Surgery
Intervention Description
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 Outcome Measure Information:
Title
Number of patients with adverse events
Description
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
Time Frame
18 months after the surgery.
Secondary Outcome Measure Information:
Title
Number of patients that regain weight
Description
Patients will be followed for 18 months after surgery and will follow-up visits to collect information about body weight.
Time Frame
18 months after the surgery.
Title
deaths
Description
Number of patients that died
Time Frame
18 months from the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo R Esselin de Melo
Organizational Affiliation
INSTITUTO PAULO REIS DE CLINICA CIRURGICA E OBESIDADE MORBIDA S/S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74125-070
Country
Brazil

12. IPD Sharing Statement

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Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

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