International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Department of Colorectal Surgery, Chinese Academy of Medical Sciences Cancer Institute and Hospital, Beijing, China.
Trials. 2021 Sep 9;22(1):610. doi: 10.1186/s13063-021-05564-3.
Postoperative ileus (POI) occurs in almost all patients after abdominal laparoscopic surgery, resulting in complications and increasing the length of hospitalization. Electroacupuncture has been used as an alternative therapy for gastrointestinal dysfunction, but its efficacy for POI is inconclusive. The study is designed to determine whether electroacupuncture can accelerate recovery from POI.
METHODS/DESIGN: This study is a three-arm, randomized controlled trial. A total of 105 patients will be randomized into a group receiving electroacupuncture at Tianshu (ST25), a group receiving electroacupuncture at Zusanli (ST36), or a control group in a 1:1:1 ratio. Patients in the electroacupuncture groups will receive electroacupuncture treatment for 4 days from the first day after surgery. The primary outcome consists of the time to first flatus and the time to first defecation. Secondary outcomes include the time to first tolerance of liquid and semiliquid food; the length of the hospital stay; postoperative pain, nausea, and vomiting; abdominal distension; the time to first get out of bed; and postoperative complications. The outcomes will be assessed by the patients themselves every day during hospitalization. Surgeons, nurses, assessors, and statisticians will be blinded to the group assignments. Patients in the two electroacupuncture groups, but not in the control group, will be blinded to the group assignments. The acupuncturists will not be blinded.
The aim of this trial is to provide a nonpharmacological therapy for POI and may provide evidence of the effect of electroacupuncture at ST25 or ST36 on POI.
Chinese Clinical Trial Registry ChiCTR1900027466 . Registered on 14 November 2019.
腹部腹腔镜手术后几乎所有患者都会出现术后肠麻痹(POI),导致并发症并增加住院时间。电针已被用作胃肠功能障碍的替代疗法,但对 POI 的疗效尚无定论。本研究旨在确定电针是否可以加速 POI 的恢复。
方法/设计:这是一项三臂、随机对照试验。共有 105 名患者将以 1:1:1 的比例随机分为电针天枢(ST25)组、电针足三里(ST36)组或对照组。电针组患者将在术后第一天开始接受为期 4 天的电针治疗。主要结局包括首次排气时间和首次排便时间。次要结局包括首次耐受液体和半流质食物的时间;住院时间;术后疼痛、恶心和呕吐;腹胀;首次下床时间;以及术后并发症。住院期间,患者每天自行评估结果。外科医生、护士、评估者和统计学家将对分组情况进行盲法评估。只有电针组的患者,而不是对照组的患者,将对分组情况进行盲法评估。针灸师不会进行盲法评估。
本试验的目的是为 POI 提供一种非药物治疗方法,并可能为 ST25 或 ST36 电针对 POI 的疗效提供证据。
中国临床试验注册中心 ChiCTR1900027466. 于 2019 年 11 月 14 日注册。