Mansfield Sara A, Kotagal Meera, Hartman Stephen, Murphy Andrew J, Davidoff Andrew M, Anghelescu Doralina L, Mecoli Marc, Cost Nicholas, Hogan Brady, Rove Kyle O
Department of Surgery, St. Jude Children's Research Hospital, Memphis, TN, United States.
Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, United States.
Front Surg. 2024 May 22;11:1393857. doi: 10.3389/fsurg.2024.1393857. eCollection 2024.
Enhanced recovery after surgery (ERAS) is an evidence-based, multi-modal approach to decrease surgical stress, expedite recovery, and improve postoperative outcomes. ERAS is increasingly being utilized in pediatric surgery. Its applicability to pediatric patients undergoing abdominal tumor resections remains unknown.
A group of key stakeholders adopted ERAS principles and developed a protocol suitable for the variable complexity of pediatric abdominal solid tumor resections. A multi-center, prospective, propensity-matched case control study was then developed to evaluate the feasibility of the protocol. A pilot-phase was utilized prior to enrollment of all patients older than one month of age undergoing any abdominal, retroperitoneal, or pelvic tumor resections. The primary outcome was 90-day complications per patient. Additional secondary outcomes included: ERAS protocol adherence, length of stay, time to administration of adjuvant chemotherapy, readmissions, reoperations, emergency room visits, pain scores, opioid usage, and differences in Quality of Recovery 9 scores.
Institutional review board approval was obtained at all participating centers. Informed consent was obtained from each participating patient. The results of this study will be presented at pertinent society meetings and published in peer-reviewed journals. We expect the results will inform peri-operative care for pediatric surgical oncology patients and provide guidance on initiation of ERAS programs. We anticipate this study will take four years to meet accrual targets and complete follow-up.
NCT04344899.
术后加速康复(ERAS)是一种基于证据的多模式方法,旨在减轻手术应激、加速康复并改善术后结局。ERAS在小儿外科手术中的应用越来越广泛。但其在接受腹部肿瘤切除术的儿科患者中的适用性尚不清楚。
一组关键利益相关者采用了ERAS原则,并制定了一个适用于小儿腹部实体肿瘤切除术不同复杂程度的方案。随后开展了一项多中心、前瞻性、倾向评分匹配的病例对照研究,以评估该方案的可行性。在纳入所有年龄大于1个月、接受任何腹部、腹膜后或盆腔肿瘤切除术的患者之前,先进行了试点阶段。主要结局是每位患者的90天并发症。其他次要结局包括:ERAS方案依从性、住院时间、辅助化疗给药时间、再入院、再次手术、急诊就诊、疼痛评分、阿片类药物使用情况以及康复质量9分的差异。
所有参与中心均获得了机构审查委员会的批准。从每位参与患者处获得了知情同意。本研究结果将在相关学会会议上公布,并发表在同行评审期刊上。我们预计研究结果将为小儿外科肿瘤患者的围手术期护理提供参考,并为启动ERAS项目提供指导。我们预计本研究将耗时四年达到入组目标并完成随访。
NCT04344899。