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临床试验/NCT05671094
NCT05671094已完成不适用

Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery: a Pilot and Feasibility Study

Jessa Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Adherence rate to the prehabilitation program

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Adherence rate to the prehabilitation program

时间窗: throughout study completion, an average of 1 year

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.

Recruitment rate

时间窗: 6 months after the start of the study

Recruitment rate is defined as excellent if 40 patients can be enrolled in this study in a time frame of 6 months.

次要结局

  • 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)
  • Incidence of Postoperative Cognitive Disorder(3 months after surgery)
  • Assessment of Patient Recovery(Baseline (before surgery) and 6 weeks after surgery.)
  • Assessment of re-admission(through study completion, an average of 3 months)
  • Complications(through study completion, an average of 3 months)
  • the 6 minutes walking test (Physical fitness)(Baseline (before surgery) and 6 weeks after surgery)
  • Physical fitness(Baseline (before surgery) and 6 weeks after surgery)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stessel Björn

Principal Investigator

Jessa Hospital

研究点 (2)

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