PROPER—PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial
Autor: | Andre Lopes, Ronaldo Lúcio Rangel Costa, Lilian Arruda do Rêgo Barros, Eduardo de Souza Neto, Marina Elisa Ribeiro da Silva, Jaqueline Nunes de Carvalho, Juliana Fenerich Mauri Andrade, Emília de Azevedo Oliveira, Thais de Campos Cardenas, Alayne Magalhães Trindade Domingues Yamada |
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Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
Genital Neoplasms Female medicine.medical_treatment Prehabilitation Psychological intervention Gynecologic oncology Preoperative care law.invention Randomized controlled trial law Laparotomy Clinical endpoint Humans Medicine Single-Blind Method Prospective Studies Gynecological surgery Randomized Controlled Trials as Topic business.industry Preoperative Exercise Obstetrics and Gynecology Length of Stay Oncology Physical therapy Female Enhanced Recovery After Surgery business |
Zdroj: | International Journal of Gynecologic Cancer. 32:195-197 |
ISSN: | 1525-1438 1048-891X |
Popis: | BackgroundPrehabilitation is a process that occurs before surgery and aims to improve patient functional capacity and enhance surgical recovery. This process includes medical, nutritional, physical, and psychological interventions that may reduce the duration of hospital stay and provide postoperative physical benefits.Primary ObjectiveTo evaluate the impact of a prehabilitation program on postoperative recovery time for patients who will undergo gynecological surgery following the Enhanced Recovery After Surgery (ERAS) guidelines.Study HypothesisA multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.Trial DesignProspective, interventionist, and randomized controlled trial in a 1:1 ratio, open to multidisciplinary team and patients, blinded to surgeons and anesthesiologists. The control group will undergo ERAS standard preoperative care while the intervention group will have ERAS standard preoperative care plus prehabilitation.Major Inclusion CriteriaPatients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks.Primary EndpointTo compare time between surgery and the day the patient is ready for discharge in patients who underwent the prehabilitation process versus those who did not. Readiness for discharge is defined as the ability to take care of one’s-self, to walk alone, and to ingest at least 75% of daily recommended calorie intake.Sample Size194 participantsEstimated Dates for Completing Accrual and Presenting ResultsAt present, 30 patients have been recruited. Accrual should be completed by 2023–24.Trial RegistrationThe study is approved by the IBCC – São Camilo Oncologia ethics committee (reference number 4.256.553) and is registered at clinicaltrials.gov (NCT04596800). |
Databáze: | OpenAIRE |
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