Clinical trial NCT02373007: Evaluation of Two Surgical Scopinaro Techniques in the Treatment of Obesity
Official title: Evaluation of Safety and Effectiveness Modified Scopinaro Technique in the Surgical Treatment of Obesity Compared to Classical Scopinaro Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Instituto Paulo Reis
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 18 months after the surgery.
Secondary outcomes:
measure: Number of patients that regain weight
timeFrame: 18 months after the surgery.
measure: deaths
timeFrame: 18 months from the surgery
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto Paulo Reis de Clinica Cirurgica E Obesidade Morbida S/S
state: Goiás
Study officials:
affiliation: INSTITUTO PAULO REIS DE CLINICA CIRURGICA E OBESIDADE MORBIDA S/S
name: Paulo R Esselin de Melo
role: PRINCIPAL_INVESTIGATOR
References: