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Pharmacoeconomic study of stomach reduction surgery

Cohort study of follow-up of participants submitted to Conventional Open Bariatric Surgery versus Laparoscopic Surgery. Clinical and pharmacoeconomic evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6h8kp2
Enrollment
Unknown
Registered
2018-10-04
Start date
2018-10-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity

Interventions

50 participants in laparoscopic bariatric surgery
50 participants in open bariatric surgery
These 100 participants with indication of bariatric surgery according to the criteria of CFM and SBCBM will have their data collected before surgery, as well as information from the surgical procedure
Procedure/surgery

Sponsors

Hospital e Maternidade São Luiz
Lead Sponsor
Hospital São Lucas
Collaborator
Inovatie Consultoria e Serviços em Saúde Ltda - ME
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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);

Design outcomes

Primary

MeasureTime frame
Difference in costs associated with laparoscopic surgery in relation to open bariatric surgery.

Secondary

MeasureTime frame
Direct medical costs in reais.;Indirect medical costs in reais. ;Time of return to work of participants undergoing bariatric surgery, in days.;Clinical recovery time of the participants undergoing bariatric surgery, in days. ;Number of complications related to procedures (adverse events related to procedures). ;Postoperative pain, measured by visual analog scale. ;Evaluation of quality of life, evaluated by the SF-36 instrument.

Countries

Brazil

Contacts

Public ContactAngela Tosi

Sociedade Brasileira de Cirurgia Bariátrica e Metabólica

angela@sbcbm.org.br+55-011-32846951

Outcome results

None listed

Source: REBEC (via WHO ICTRP)