Pharmacoeconomic study of stomach reduction surgery
- Conditions
- obesitybariatric surgeryE02.570.500.062C18.654.726.500
- Registration Number
- RBR-6h8kp2
- Lead Sponsor
- Hospital e Maternidade São Luiz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Sign the TCLE approved by the CEP; Men and women, older than 18 years; To present a BMI greater than or equal to 35 kg / m2 associated with comorbidities or to have a BMI greater than 40 kg / m2; Clinical intractability of obesity observed by endocrinologist; Established indication for indication of bariatric surgery according to the Brazilian Society of Bariatric and Metabolic Surgery (SBCBM) and Resolution 2.131 of 2015 of the Federal Council of Medicine (CFM).
Anesthesia risk classified as ASA IV; Portal hypertension with esophagogastric varices; Significant intellectual limitation; Current uncontrolled psychiatric disorder; Regular users of alcohol or illicit drugs; Any other prior disease that in the opinion of the investigator contraindicates participation in the study; Women of childbearing age without adequate contraception or infants; Participation in another clinical study in less than 1 year (unless justified by the investigator);
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in costs associated with laparoscopic surgery in relation to open bariatric surgery.
- Secondary Outcome Measures
Name Time Method Direct medical costs in reais.;Indirect medical costs in reais.<br>;Time of return to work of participants undergoing bariatric surgery, in days.;Clinical recovery time of the participants undergoing bariatric surgery, in days.<br>;Number of complications related to procedures (adverse events related to procedures).<br>;Postoperative pain, measured by visual analog scale.<br>;Evaluation of quality of life, evaluated by the SF-36 instrument.