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Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity

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ClinicalTrials.gov Identifier: NCT02373007
Recruitment Status : Unknown
Verified April 2016 by Paulo Reis Esselin de Melo, Instituto Paulo Reis.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Paulo Reis Esselin de Melo, Instituto Paulo Reis

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Scopinaro Surgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness Modified Scopinaro Technique in the Surgical Treatment of Obesity Compared to Classical Scopinaro Technique
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 18 months after the surgery. ]
    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 :
  1. Number of patients that regain weight [ Time Frame: 18 months after the surgery. ]
    Patients will be followed for 18 months after surgery and will follow-up visits to collect information about body weight.

  2. deaths [ Time Frame: 18 months from the surgery ]
    Number of patients that died



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373007


Locations
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Brazil
Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S
Goiânia, Goiás, Brazil, 74125-070
Sponsors and Collaborators
Instituto Paulo Reis
Investigators
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Principal Investigator: Paulo R Esselin de Melo INSTITUTO PAULO REIS DE CLINICA CIRURGICA E OBESIDADE MORBIDA S/S
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Responsible Party: Paulo Reis Esselin de Melo, Instituto Paulo Reis
ClinicalTrials.gov Identifier: NCT02373007    
Other Study ID Numbers: UTN U1111-1166-7218
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight