Obesity
Conditions
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.
Interventions
PROCEDUREScopinaro 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.
Sponsors
Instituto Paulo Reis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that regain weight | 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. |
| deaths | 18 months from the surgery | Number of patients that died |
Countries
Brazil
Outcome results
None listed