Prostate Cancer Clinical Trial
Official title:
Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery: a Pilot and Feasibility Study
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 | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence rate to the prehabilitation program | Protocol adherence is defined as excellent if 80% of patients were fully adherent to the prehabilitation program. Full adherence is defined as adherence to all 4 different prehabilitation program components (see above). Adherence to the physical component will be assessed by the physical medicine and rehabilitation physician, responsible for this component. Adherence to the nutrition component will be assessed by the dietician, responsible for coaching of patients with nutrition. The other 2 components will be assessed by the study team at the end of the program. | throughout study completion, an average of 1 year | |
Primary | Recruitment rate | Recruitment rate is defined as excellent if 40 patients can be enrolled in this study in a time frame of 6 months. | 6 months after the start of the study | |
Secondary | Incidence of Postoperative Cognitive Disorder | A battery of four tests (Rey Auditory Verbal Learning Test (RAVLT), Trial Making Test (TMT A and B) and the Grooved Pegboard Test) mentioned by the 'statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery', published in 1995 supplemented with two additional tests (ie, the Welscher Adult Intelligence Scale (WAIS)-III digit span test and WAIS-III digit symbol-coding test) will be administered to determine the cognitive outcome. LPOCD is defined as an RCI (Reliable Change Index) =-1.645 (significance level 5%) or Z-score =-1.645 in at least two different tests. | 3 months after surgery | |
Secondary | Assessment of Patient Recovery | This will be assessed with the WHO Disability Assessment Schedule 2.0 (WHODAS) questionnaire. | Baseline (before surgery) and 6 weeks after surgery. | |
Secondary | Assessment of quality of recovery | Quality of recovery will be assessed through the QoR-40 questionnaire. | Baseline (before surgery) and 24 hours after surgery | |
Secondary | Hospital length of stay | Data regarding hospital admission and discharge will be collected. | through study completion, an average of 3 months | |
Secondary | Assessment of amount of red blood cell transfusion | Assessment of amount of red blood cell transfusion during the surgery and the stay in hospital. | throughout study completion, an average of 3 months | |
Secondary | Assessment of re-admission | Evaluation regarding re-admission during 3 months post-operatively will be collected | through study completion, an average of 3 months | |
Secondary | Complications | Assessment of complications | through study completion, an average of 3 months | |
Secondary | the 6 minutes walking test (Physical fitness) | Assessment of physical fitness with the 6 minutes walking test | Baseline (before surgery) and 6 weeks after surgery | |
Secondary | Physical fitness | Assessment of physical fitness with the timed up and go test | Baseline (before surgery) and 6 weeks after surgery |
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