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Not Yet Recruiting NCT05671094

Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery

Conditions: Prostate Cancer, Gynecologic Cancer

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Jessa Hospital

Summary

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 patientsHence, 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.

Eligibility Criteria

Inclusion Criteria:Adult patients (≥ 18 years)Competent to provide informed consentUndergoing robotic oncological urological or gynaecological surgery in ≥ 30 days from enrollment.Fluent in DutchExclusion Criteria:Premorbid conditions or orthopedic impairments with contraindications to exerciseCognitive disabilities defined as evolutive neurological or neurodegenerative diseaseASA score 4 or higher or patient under palliative careExpected length of stay at hospital < 48 hoursPatient under tutorship or curatorshipPregnant or breast-feeding womanAbsence of informed consent or request to not participate to the study

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Source: ClinicalTrials.gov (NCT05671094). StuddyBuddy aggregates publicly available trial information.