Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

NCT ID: NCT02373007

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Classic Scopinaro Surgery

Patients will get the Bariatric surgery using the Classic Scopinaro Techniques

Group Type: OTHER

Scopinaro Surgery

Intervention Type: 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.

Modified Scopinaro Surgery

Patients will get Bariatric surgery using the Modified Scopinaro Techniques

Group Type: OTHER

Scopinaro Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Paulo Reis

OTHER

Sponsor Role: lead

Responsible Party

Paulo Reis Esselin de Melo

Paulo Reis Esselin de Melo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo R Esselin de Melo

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Goiânia, Goiás, Brazil

Countries

Brazil

Other Identifiers

UTN U1111-1166-7218

Identifier Type: -

Identifier Source: org_study_id