Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

Evaluation of Safety and Effectiveness Modified Scopinaro Technique in the Surgical Treatment of Obesity Compared to Classical Scopinaro Technique

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Procedure: Scopinaro Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Goiás
    • Goiânia, Goiás, Brazil, 74125-070
      • Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Classic Scopinaro Surgery; Patients will get the Bariatric surgery using the Classic Scopinaro Techniques	Procedure: 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: Modified Scopinaro Surgery; Patients will get Bariatric surgery using the Modified Scopinaro Techniques	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months after the surgery.
deaths	Number of patients that died	18 months from the surgery

Collaborators and Investigators

• Sponsor: Instituto Paulo Reis
• Investigators: Principal Investigator: Paulo R Esselin de Melo, Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: UTN U1111-1166-7218