术前电针与假电针治疗中国腹腔镜结直肠癌手术后肠梗阻的比较:一项多中心、随机、假对照试验的研究方案。
Preoperative electroacupuncture versus sham electroacupuncture for the treatment of postoperative ileus after laparoscopic surgery for colorectal cancer in China: a study protocol for a multicentre, randomised, sham-controlled trial.
发表日期:2024 Jul 05
作者:
Yi-Ming Fu, Ying-Chi Yang, Jing Zhang, Jingjie Zhao, Gong-Yong Liu, Shen Ling, Chao Wang, Li-Wei Wang, Yu-Tong Yang, Yu Wang, Na-Na Yang, Cun-Zhi Liu, Wei Pei
来源:
PHYSICAL THERAPY & REHABILITATION JOURNAL
摘要:
术后肠梗阻(POI)是一种术后并发症,可能导致结直肠切除术后恢复期较长,并给医疗系统带来沉重负担。针灸旨在预防术后并发症、缩短 POI 持续时间、帮助康复并缩短住院时间。我们假设POI患者在腹腔镜手术后,术前电针(EA)可以在加速康复外科方案下促进POI恢复。这是一项多中心、随机、假对照试验。总共 80 名患者将被纳入并随机分配到 EA 组或假电针 (SA) 组。符合条件的患者将每天接受一次 EA 或 SA 治疗,治疗频率从术前第 1 天开始,连续四天。主要结果是第一次排便的时间。次要结局包括首次排气时间、术后住院时间、半流质和固体食物耐受时间、术后恶心、呕吐、疼痛和腹胀程度、首次下床活动时间、术前焦虑、30天再入院率、手术期间麻醉剂和镇痛剂的使用情况、麻醉后在监护室停留的时间。通过单细胞 RNA 测序进行机制研究,其中将收集干预后的正常肠道组织样本。这项研究的结果将为针灸对 POI 的影响提供证据,并促进全球每年数以百万计的患者做出良好的临床决策。这项研究已获得北京中医药大学伦理申请(2022BZYLL0401)、北京友谊医院的批准首都医科大学附属(2022-P2-368-02)、中国医学科学院肿瘤医院(23/175-3917)、环兴肿瘤医院(2023-002-02)。结果将发表在医学杂志上。此外,我们计划在科学会议上展示它们。ChiCTR2300077633.© 作者(或其雇主)2024。在 CC BY-NC 下允许重复使用。禁止商业再利用。请参阅权利和权限。由英国医学杂志出版。
Postoperative ileus (POI) is a postoperative complication that can cause lingering recovery after colorectal resection and a heavy healthcare system burden. Acupuncture aims to prevent postoperative complications, reduce the duration of POI, help recovery and shorten hospital stays. We hypothesise that preoperative electroacupuncture (EA) can promote POI recovery under the enhanced recovery after surgery protocol after laparoscopic surgery in patients with POI.This is a multicentre, randomised, sham-controlled trial. A total of 80 patients will be enrolled and randomly assigned to the EA or sham electroacupuncture (SA) group. The eligible patients will receive EA or SA for one session per day with treatment frequency starting on preoperative day 1 for four consecutive days. The primary outcome is the time to first defecation. The secondary outcomes include the time to first flatus, length of postoperative hospital stay, time to tolerability of semiliquid and solid food, postoperative nausea, vomiting, pain and extent of abdominal distention, time to first ambulation, preoperative anxiety, 30-day readmission rate, the usage of anaesthetics and analgesics during operation, length of postanaesthesia care unit stay. A mechanistic study by single-cell RNA sequencing in which postintervention normal intestinal tissue samples will be collected. The results of this study will provide evidence of the effects of acupuncture on POI and promote good clinical decision to millions of patients globally every year.This study has been approved by the ethical application of Beijing University of Chinese Medicine (2022BZYLL0401), Beijing Friendship Hospital Affiliated to Capital Medical University(2022-P2-368-02), Cancer Hospital Chinese Academy of Medical Science (23/175-3917), Huanxing Cancer Hospital (2023-002-02). The results will be published in a medical journal. In addition, we plan to present them at scientific conferences.ChiCTR2300077633.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.