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保留神经的根治性前列腺切除术患者多学科术前康复的详细描述——一项随机可行性研究方案

Detailed description of multidisciplinary prehabilitation in patients admitted to nerve sparring radical prostatectomy - A randomized feasibility study protocol.

作者信息

Blumenau Pedersen Malene, Saxton John M, Rasmussen Villumsen Brigitta, Bjerggaard Jensen Jørgen, Birch Sara

机构信息

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

Department of Urology, Gødstrup Hospital, Gødstrup, Denmark.

出版信息

Contemp Clin Trials Commun. 2024 Jun 10;40:101319. doi: 10.1016/j.conctc.2024.101319. eCollection 2024 Aug.

Abstract

BACKGROUND

Localized prostate cancer treated with radical prostatectomy is highly effective, though severe side-effects are common after the surgery. Prehabilitation is an approach to optimize patient's physical and mental resources before surgery, to improve postoperative outcomes. The feasibility of a multi-modal home-based prehabilitation program, delivered using telehealth in patients awaiting radical prostatectomy is unknown. This paper describes the development of a prehabilitation program for patients awaiting radical prostatectomy.

METHOD

A model by The Medical Research Council for developing and evaluating complex interventions (MRC Framework) was used in the development process. The Template for Intervention Description and Replication (TIDieR) checklist was applied for ensuring sufficient description of the interventions. A total of 40 patients will be randomized to either intervention or control group. Patients in the control group will follow standard care. The 4-week prehabilitation programme consists of exercise, pelvic floor exercise, sexual counseling, stress management and nutritional support. The interventions are home-based and delivered using telehealth. Feasibility outcomes will include recruitment, attrition rates, adherence, safety and suitability.

CONCLUSION

We have developed a multimodal prehabilitation programme, which has the potential to bring tangible health benefits to men with prostate cancer awaiting radical prostatectomy. The results of the feasibility study will inform the design of a fully powered randomized controlled trial.

摘要

背景

根治性前列腺切除术治疗局限性前列腺癌疗效显著,不过术后严重副作用较为常见。术前康复是一种在手术前优化患者身心资源以改善术后结果的方法。对于等待根治性前列腺切除术的患者,通过远程医疗实施多模式居家术前康复计划的可行性尚不清楚。本文描述了一项针对等待根治性前列腺切除术患者的术前康复计划的制定情况。

方法

在制定过程中采用了医学研究理事会用于开发和评估复杂干预措施的模型(MRC框架)。应用干预描述与复制模板(TIDieR)清单以确保对干预措施进行充分描述。总共40名患者将被随机分为干预组或对照组。对照组患者将接受标准护理。为期4周的术前康复计划包括运动、盆底肌锻炼、性咨询、压力管理和营养支持。这些干预措施以家庭为基础并通过远程医疗实施。可行性结果将包括招募情况、失访率、依从性、安全性和适用性。

结论

我们已经制定了一项多模式术前康复计划,该计划有可能为等待根治性前列腺切除术的前列腺癌患者带来切实的健康益处。可行性研究结果将为全面的随机对照试验设计提供参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/575e/11211855/751cec595d19/gr1.jpg

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