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Doctoral Thesis
DOI
https://doi.org/10.11606/T.5.2019.tde-08112019-104140
Document
Author
Full name
Tatiana Morgado Conte
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2019
Supervisor
Committee
Haddad, Luciana Bertocco de Paiva (President)
Cassenote, Alex Jones Flores
Gagliardi, Danilo
Moura, Eduardo Guimarães Hourneaux de
Title in Portuguese
Custo-utilidade da miotomia endoscópica peroral (POEM) comparada a miotomia laparoscópica a Heller associada à fundoplicatura em pacientes portadores de acalasia
Keywords in Portuguese
Acalasia esofágica
Anos de vida ajustados por qualidade de vida
Custos e análise de custos
Endoscopia
Gastroenterologia
Heller miotomia
Abstract in Portuguese
Introdução: A acalasia e uma desordem benigna da motilidade esofagica, caracterizada pela aperistalse do esfincter esofagico inferior. Disfagia progressiva de solidos para liquidos e o principal sintoma. Estudos recentes vem mostrando efetividades clinicas similares entre a miotomia endoscopica peroral (POEM) e a miotomia laparoscopica a Heller associada a fundoplicatura (MLHF). Adicionalmente, os custos e a qualidade de vida do paciente devem ser considerados para a escolha da melhor tecnica terapeutica. Objetivo: Analise de custo-utilidade comparando o POEM com a MLH-F em pacientes portadores de acalasia. Materiais e métodos: Avaliacao economica de custo-utilidade do tipo piggy-back, com horizonte temporal de um ano e duracao de ciclo de tres meses, sob perspectiva de um hospital publico terciario. Foram recrutados pacientes com acalasia sintomatica, com idade entre 18 e 60 anos, randomizados para o POEM ou MLH-F entre Jan/16 a Jan/17. Os valores monetarios foram extraidos atraves da intranet da instituicao pela metodologia de microcusteio. Foram inclusos todos os custos com os procedimentos, internacao hospitalar, acompanhamento clinico e complicacoes terapeuticas. Os dados de utilidade foram mensurados pelos anos de vida ajustados a qualidade (QALY), a qual foi estimado pelo escore de um questionario de qualidade de vida. A diferenca entre o escore inicial e final do QALY foi considerado diretamente relacionado a terapeutica. A analise de custo-efetividade foi calculada pela razao de custo utilidade (RCUI). Foi realizada uma analise de sensibilidade com os dados de custo dos pacientes com e sem complicacao e do hemoclipe hemostatico. Resultados: Quarenta pacientes (POEM=20 e MLHF= 20) foram randomizados, com prevalencia do sexo masculino, faixa etaria na quarta decada de vida e etiologia idiopatica. Sucesso tecnico foi de 100% em ambos os grupos, apesar de terem sido evidenciadas 21 complicacoes, das quais 76% ocorreram no grupo endoscopico (p=0,016). Pacientes submetidos ao POEM permaneceram, em media, 1,5 dias menos internados (p=0,009) e nao necessitaram de internacao hospitalar em unidade de terapia intensiva. Um paciente no grupo endoscopico apresentou recidiva tardia da disfagia ao longo do horizonte temporal. Os custos finais, com o grupo endoscopico e cirurgico, foram, respectivamente R$9.834,36 e R$6.395,58 por paciente (p < 0,001). A diferenca entre o QALY final e inicial foi de 0,434 para o POEM e 0,332 para a MLH-F (p=0,397). O resultado da RCUI foi R$33.713,53/QALY, evidenciando que o POEM e uma estrategia mais cara e ligeiramente mais efetiva do que a MLH-F. As analises de sensibilidade evidenciaram que dependendo do cenario analisado, o POEM pode ser uma estrategia mais ou menos custo-efetiva, embora continue sendo mais caro e mais efetivo que a MLH-F. Conclusão: A curto prazo, o POEM e uma tecnologia segura e de melhor custo-utilidade em relacao a MLH-F. No entanto, como nova terapeutica, a extensao dos resultados mudam com o amadurecimento da tecnica, assim, recomenda-se a realizacao de novos estudos, com horizontes temporais maiores para obtencao de resultados mais consolidados que contribuam com os achados deste trabalho
Title in English
Cost-utility of peroral endoscopic myotomy (POEM) compared to laparoscopic Heller's myotomy associated with dor fundoplication in patients with achalasia
Keywords in English
Costs and cost analysis
Endoscopy
Esophageal achalasia
Gastroenterology
Heller myotomy
Quality-adjusted life years
Abstract in English
Introduction: Achalasia is a benign disorder of esophageal motility, characterized by aperistalse of the lower esophageal sphincter. Progressive dysphagia from solids to liquids is the most important symptom. Recent studies have shown similar clinical efficacies between peroral endoscopic myotomy (POEM) and laparoscopic Heller's myotomy associated with fundoplication (MLHF). In addition, the patient's costs and quality of life should be considered when choosing the best therapeutic technique. Objective: Cost-utility analysis of POEM and MLH-F to the patients with achalasia. Methodology: An economic cost-utility analysis was done, with a time horizon of one year and a cycle duration of three months from the perspective of a tertiary public hospital. Patients with symptomatic achalasia, age between 18 to 60 years old was recruited between Jan/16 and Jan/17 and randomized to POEM or MLH-F. Monetary values were extracted from the institution´s intranet through micro-accounting methodology. All costs were included with the procedure, hospitalization, follow-up and complications. The utility data were measured by quality-adjusted life years (QALY), which was estimated from the scores of a quality of life questionnaire. The difference of QALY initial and final was associated with the procedure. The cost-effectiveness analysis was calculated by the incremental utility cost ratio (RCUI). A sensitivity analysis was performed by varying the cost with or not complications and with the clip hemostatic. Results: Forty patients (POEM=20 and MLH-F=20) were randomized. There was a prevalence of males, age in the fourth decade of life, and idiopathic etiology. Technical success was 100% in both groups, although 21 complications were evidenced, of which 76% occurred in the endoscopic group (p=0,016). Patients submitted to POEM remained, on average, 1.5 days less hospitalized (p=0,009) and they didn´t hospitalized in intensive care unit. One patient in the endoscopic group had late recurrence of dysphagia along the time horizon. The final costs, with the endoscopic and surgical group, were, respectively, R$ 9.834,36 and R$6.395,58 per patient. The difference between the initial and final QALY was 0.434 for the POEM and 0.322 for the MLH-F (p=0,397). The result of the RCUI was R$33.713,53/QALY, evidencing that the POEM is more expensive but more slightly effective than MLH-F. The sensitivity analyzes showed that depending on the scenario analyzed, the POEM may or may not be more or less cost-effective strategy than MLH-F. Conclusion: In the sort-term, POEM is a safe and better cost-utility than MLH-F. However, as a new therapy, the extensions of the results change with the maturation of the technique, therefore, we recommend new studies with long-term horizons to improve the results of this study
 
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Publishing Date
2019-12-04
 
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