Clinical trial NCT05671094: Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery
Official title: Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Gynecologic Cancer
Keywords: Prehabilitation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Detailed description: The main elements of established enhanced recovery after surgery (ERAS) include a minimally invasive surgical approach when feasible, locoregional analgesia, limited use and duration of drains, minimized blood loss and perioperative fluid administration, early oral re-nutrition, respiratory physiotherapy, and early mobilization. These pathways have demonstrated to be beneficial in the oncological surgery field by reducing hospitalization costs and peri-operative complications, while maintaining suitable oncological and functional outcomes. It has to be emphasized that patients who are active and well-functioning prior to surgery, have fewer complications, recuperate faster, and experience better recovery compared to their less fit counterparts. Recently, prehabilitation as a strategy to begin the rehabilitation process before surgery gains more interest. Although there is no single definition of prehabilitation available, this intervention aims to actively prepare patients before surgery through exercise, nutritional support, psycho-cognitive training or a combination thereof.

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.

Study design

This is an observer-blind, randomized controlled, superiority trial. All participants will receive standardized perioperative care according to established ERAS protocols (main elements include a minimally invasive surgical approach when feasible, locoregional analgesia, limited use and duration of drains, minimized blood loss and perioperative fluid administration, early oral re-nutrition, respiratory physiotherapy, and early mobilization).

The standard preoperative pathway includes risk assessment, medication management and perioperative blood management.

Randomization

Patients will be randomly assigned in a 1:1 ratio to either of the two study groups: an intervention group undergoing the prehabilitation program and a control group. A block randomization of 4, stratified per type of surgery, will be performed using a computer-generated random allocation sequence, created by the study statistician. Allocation numbers will be sealed in opaque envelopes, which will be opened in sequence by an unblinded member of the study team after enrollment of a patient into the study. The randomization list will remain with the study statistician for the whole duration of the study.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence rate to the prehabilitation program
timeFrame: throughout study completion, an average of 1 year
measure: Recruitment rate
timeFrame: 6 months after the start of the study
Secondary outcomes:
measure: Incidence of Postoperative Cognitive Disorder
timeFrame: 3 months after surgery
measure: Assessment of Patient Recovery
timeFrame: Baseline (before surgery) and 6 weeks after surgery.
measure: Assessment of quality of recovery
timeFrame: Baseline (before surgery) and 24 hours after surgery
measure: Hospital length of stay
timeFrame: through study completion, an average of 3 months
measure: Assessment of amount of red blood cell transfusion
timeFrame: throughout study completion, an average of 3 months
measure: Assessment of re-admission
timeFrame: through study completion, an average of 3 months
measure: Complications
timeFrame: through study completion, an average of 3 months
measure: the 6 minutes walking test (Physical fitness)
timeFrame: Baseline (before surgery) and 6 weeks after surgery
measure: Physical fitness
timeFrame: Baseline (before surgery) and 6 weeks after surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: