Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02373007
• Other study ID #: UTN U1111-1166-7218
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 5, 2015
• Last updated: April 26, 2016
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Instituto Paulo Reis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S	Goiânia	Goiás

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Paulo Reis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes
Secondary	deaths	Number of patients that died	18 months from the surgery	Yes