Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery

NCT05671094 | Completed

• 1 other identifier: f/2022/154
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Gynecologic Cancer

Keywords

Prehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Incidence of Postoperative Cognitive Disorder

  3 months after surgery

• Assessment of Patient Recovery

  Baseline (before surgery) and 6 weeks after surgery.

• Assessment of quality of recovery

  Baseline (before surgery) and 24 hours after surgery

• Hospital length of stay

  through study completion, an average of 3 months

• Assessment of amount of red blood cell transfusion

  throughout study completion, an average of 3 months

Study Arms (2)

Control group

NO INTERVENTION

Standard of care, i.e no specific program prior to surgery.

Prehabilitation group

EXPERIMENTAL

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.

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Physical, mental, stress reducing and dietary prehabilitation programme, 4 to 2 weeks before surgery

Prehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All treating physicians including surgical team, attending anesthetist and surgeon, all researcher assessing outcomes (i.e. study nurse + surgeon) and the data-managers will be blinded for group allocation until the end of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 4, 2023
• Study Start: January 13, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)