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Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery

Abstract

Introduction Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions—physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care.

Methods and analysis This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission.

Ethics and dissemination This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository.

Trial registration number NCT02921932 (ClinicalTrials.gov)

  • Frailty
  • Prehabilitation
  • Protocol

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Footnotes

  • Contributors HRA: designed and conceptualised study, prepared draft manuscript, revised draft manuscript, approved final manuscript for submission, statistical calculations. VPX, HKO, PLE,SAK: designed and conceptualised study, revised draft manuscript, approved final manuscript for submission. YH: designed and conceptualised study, revised draft manuscript, approved final manuscript for submission, statistical calculations. CWL: designed and conceptualised study, prepared draft manuscript, revised draft manuscript, approved final manuscript for submission. All the authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This trial is supported by the Singhealth Foundation Transition Project Grant (SHF/HSRAg002/2015). Thes funding source, Singhealth Foundation, has no role in the design of this study and will not have a role in the analysis and interpretation of the results.

  • Competing interests None declared.

  • Patient consent Consent of the participants will be obtained.

  • Ethics approval Singhealth Institutional Review Board.

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

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