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NCT05671094Completed

Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery

Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery: a Pilot and Feasibility Study

Source: ClinicalTrials.gov · Last updated 14 May 2025

Brief summary (registry, in English)

Current literature on prehabilitation is broad and heterogenous. Ploussard et al initiated a multimodal one-day prehabilitation program in patients before robotic radical prostatectomy involving urology nurses, anaesthetic nurses, oncology nurse specialists, anesthesiologists, dieticians, physiotherapists etc, and observed significant improvement in terms of reduction in length of stay, blood loss, and operative time, and an increase in the proportion of ambulant surgery. Santa Mina et al observed that patients following a home-based moderate-intensity exercise prehabilitation program prior to radical prostatectomy were more fit i.e have a greater score on the 6 minutes' walk test, four weeks postoperatively compared to a control group. Regrettably, this study couldn't demonstrate a difference in length of stay or complication rate. To date, evidence for efficacy of prehabilitation in gynaecological cancer patients is limited. Several reviews and a meta-analysis indicate that the level of evidence suggesting that prehabilitation may improve postoperative outcomes is low. Moreover, there is a wide variability in applied preoperative prehabilitation programs i.e, with a uni- or multimodal approach, home-based or supervised, differences in intensity and a variety of outcomes. Therefore, there is a need for randomized controlled trials with low risk of bias and clearly defined outcome parameters to clarify the potential benefit of prehabilitation for patients Hence, the primary goal of this randomized pilot study is to determine the feasibility of the implementation of a multimodal prehabilitation program in patients undergoing robotic oncologic urological or gynaecological surgery in a Belgian tertiary center in terms of protocol adherence and recruitment rate.

Status (registry)
Completed
Study type
Interventional
Enrollment
21 (actual)
First submitted
20 Dec 2022
Start date
13 Jan 2023
Primary completion date
19 Dec 2023
Lead sponsor
Jessa Hospital
NCT number
NCT05671094

What you commit to

  • Study type: Interventional
  • Participants enrolled: 21
  • From 13 Jan 2023 to the primary completion date, 19 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Premorbid conditions or orthopedic impairments with contraindications to exercise
  • Cognitive disabilities defined as evolutive neurological or neurodegenerative disease

Other

  • ASA score 4 or higher or patient under palliative care
  • Expected length of stay at hospital \< 48 hours
  • Patient under tutorship or curatorship
  • Pregnant or breast-feeding woman
  • Absence of informed consent or request to not participate to the study

Who the study is looking for

  • Adult patients (≥ 18 years)
  • Competent to provide informed consent
  • Undergoing robotic oncological urological or gynaecological surgery in ≥ 30 days from enrollment.
  • Fluent in Dutch

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jessa Hospital
Coordinator of this site? Confirm its status
HasseltBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.