Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, PO Box M157, Missenden Road, Sydney, NSW, 2050, Australia.
Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
BMC Cancer. 2022 Apr 22;22(1):443. doi: 10.1186/s12885-022-09492-6.
Radical surgery is the mainstream treatment for patients presenting with advanced primary or recurrent gastrointestinal cancers; however, the rate of postoperative complications is exceptionally high. The current evidence suggests that improving patients' fitness during the preoperative period may enhance postoperative recovery. Thus, the primary aim of this study is to establish the effectiveness of prehabilitation with a progressive, individualised, preoperative exercise and education program compared to usual care alone in reducing the proportion of patients with postoperative in-hospital complications. The secondary aims are to investigate the effectiveness of the preoperative intervention on reducing the length of intensive care unit and hospital stay, improving quality of life and morbidity, and reducing costs.
This is a multi-centre, assessor-blinded, pragmatic, comparative, randomised controlled trial. A total of 172 patients undergoing pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy will be recruited. Participants will be randomly allocated to prehabilitation with a preoperative exercise and education program (intervention group), delivered over 4 to 8 weeks before surgery by community physiotherapists/exercise physiologists, or usual care alone (control group). The intervention will comprise 12 to 24 individualised, progressive exercise sessions (including aerobic/anaerobic, resistance, and respiratory exercises), recommendations of home exercises (16 to 32 sessions), and daily incidental physical activity advice. Outcome measures will be collected at baseline, the week prior to surgery, during the hospital stay, and on the day of discharge from hospital, and 1 month and 1 months postoperatively. The primary outcome will be the development of in-hospital complications. Secondary outcomes include the length of intensive care unit and hospital stay, quality of life, postoperative morbidity and costs.
The successful completion of this trial will provide robust and high-quality evidence on the efficacy of a preoperative community- and home-based exercise and education intervention on important postoperative outcomes of patients undergoing major gastrointestinal cancer surgery.
This trial was registered prospectively with the Australian New Zealand Clinical Trials Registry ( ACTRN12621000617864 ) on 24th May 2021.
根治性手术是治疗晚期原发性或复发性胃肠道癌症患者的主流治疗方法；然而，术后并发症的发生率极高。目前的证据表明，在术前阶段改善患者的健康状况可能会促进术后恢复。因此，本研究的主要目的是确定与单纯常规护理相比，采用渐进式、个体化的术前运动和教育方案进行预康复治疗，在降低术后住院并发症发生率方面的效果。次要目的是研究术前干预对减少重症监护病房和住院时间、提高生活质量和减少发病率以及降低成本的有效性。
这是一项多中心、评估者设盲、实用、比较、随机对照试验。共招募 172 名接受盆腔切除术、减瘤性手术、食管切除术、肝切除术、胃切除术或胰切除术的患者。参与者将被随机分配到接受术前运动和教育方案的预康复组（干预组），由社区物理治疗师/运动生理学家在术前 4 至 8 周内提供，或仅接受常规护理（对照组）。干预措施将包括 12 至 24 次个体化、渐进性的运动课程（包括有氧运动/无氧运动、阻力运动和呼吸运动）、家庭运动建议（16 至 32 次）和日常偶然体力活动建议。在基线、手术前一周、住院期间和出院当天，以及术后 1 个月和 1 个月时收集结果测量值。主要结局是发生院内并发症。次要结局包括重症监护病房和住院时间、生活质量、术后发病率和成本。
该试验的成功完成将为接受重大胃肠道癌症手术的患者提供强有力的、高质量的证据，证明术前社区和家庭为基础的运动和教育干预对重要术后结局的有效性。
本试验于 2021 年 5 月 24 日前瞻性地在澳大利亚新西兰临床试验注册中心（ACTRN12621000617864）注册。
