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PROPER—PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial
  1. Andre Lopes1,2,
  2. Alayne Magalhães Trindade Domingues Yamada2,
  3. Thais de Campos Cardenas3,
  4. Jaqueline Nunes de Carvalho4,
  5. Emília de Azevedo Oliveira5,
  6. Marina Elisa Ribeiro da Silva5,
  7. Juliana Fenerich Mauri Andrade2,
  8. Eduardo de Souza Neto6,
  9. Lilian Arruda do Rêgo Barros2 and
  10. Ronaldo Lúcio Rangel Costa1
  1. 1Departamento de Ginecologia, Sao Camilo Oncologia, Sao Paulo, Brazil
  2. 2Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil
  3. 3Centro Universitário São Camilo, Sao Paulo, Brazil
  4. 4Serviço de Nutrição e Dietética, São Camilo Oncologia, Sao Paulo, Brazil
  5. 5Equipe Multidisciplinar, São Camilo Oncologia, Sao Paulo, Brazil
  6. 6Departamento de Anestesiologia, Sao Camilo Oncologia, Sao Paulo, Brazil
  1. Correspondence to Dr Andre Lopes, Departamento de Ginecologia, Sao Camilo Oncologia, 03102 Sao Paulo, Brazil; andrelopes.cirurgia{at}gmail.com

Abstract

Background Prehabilitation 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 Objective To 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 Hypothesis A 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 Design Prospective, 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 Criteria Patients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks.

Primary Endpoint To 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 Size 194 participants

Estimated Dates for Completing Accrual and Presenting Results At present, 30 patients have been recruited. Accrual should be completed by 2023–24.

Trial Registration The study is approved by the IBCC – São Camilo Oncologia ethics committee (reference number 4.256.553) and is registered at clinicaltrials.gov (NCT04596800).

  • preoperative care
  • postoperative care
  • surgical procedures
  • operative
  • laparotomy

Data availability statement

Data are available upon request.

Statistics from Altmetric.com

Data availability statement

Data are available upon request.

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Footnotes

  • Twitter @andrelopesMD

  • Contributors Conception and design: all authors performed significant contributions regarding the concept and design of the study. Manuscript writing: all authors. Final approval of manuscript: all authors. Guarantor of the article: AL.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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