Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Standard of care, i.e no specific program prior to surgery.
- type
- EXPERIMENTAL
- label
- Prehabilitation group
- description
- A multimodal prehabilitation program including 4 different components (physical, cognitive, nutritional and stress reduction prehabilitation) will be proposed to patients in order for them to participate during four to two weeks pre-operatively.
- interventionNames
- Behavioral: Prehabilitation
Primary outcomes (2)
- measure
- Adherence rate to the prehabilitation program
- timeFrame
- throughout study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (≥ 18 years) * Competent to provide informed consent * Undergoing robotic oncological urological or gynaecological surgery in ≥ 30 days from enrollment. * Fluent in Dutch Exclusion Criteria: * Premorbid conditions or orthopedic impairments with contraindications to exercise * Cognitive disabilities defined as evolutive neurological or neurodegenerative disease * 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
References
Publications (0)
Data not yet available