Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.
Department of Anesthesiology, Beijing Huimin Hospital, Beijing, China.
Trials. 2020 Jul 6;21(1):617. doi: 10.1186/s13063-020-04470-4.
Postoperative gastrointestinal (GI) dysfunction (PGD) is a common problem after abdominal surgery. PGD can increase the length of hospital stay and may lead to serious complications. Acupuncture and moxibustion are alternative therapies for PGD that have been used in some settings. However, the effect of preventive application of acupuncture or transcutaneous electrical acupuncture stimulation (TEAS) is still uncertain. The purpose of this study is to investigate the efficacy of the continuous application of TEAS on GI function recovery in adults undergoing abdominal surgery. At the same time, we will try to confirm the mechanism of TEAS through the brain-gut axis.
METHODS/DESIGN: This study is a prospective, single-center, two-arm, randomized controlled trial that will be performed in a general hospital. In total, 280 patients undergoing abdominal surgery were stratified by type of surgery (i.e. gastric or colorectal procedure) and randomized into two treatment groups. The experimental group will receive TEAS stimulation at L14 and PC6, ST36 and ST37. The sham group will receive pseudo-TEAS at sham acupoints. The primary outcome will be the time to the first bowel motion by auscultation. The recovery time of flatus, defecation, the changes in perioperative brain-intestinal peptides, postoperative pain, perioperative complications, and hospitalization duration will be the secondary outcomes.
The results of this study will demonstrate that continuous preventive application of TEAS can improve the GI function recovery in patients undergoing abdominal surgery and that this effect may act through brain-gut peptides.
Chinese Clinical Trial Registry, ChiCTR1900023263 . Registered on 11 May 2019.
术后胃肠(GI)功能障碍(PGD)是腹部手术后的常见问题。PGD 会延长住院时间,并可能导致严重的并发症。针刺和艾灸是用于治疗 PGD 的替代疗法,已在某些情况下使用。然而,预防性应用针刺或经皮电针刺激(TEAS)的效果仍不确定。本研究旨在探讨腹部手术后成人连续应用 TEAS 对胃肠功能恢复的疗效。同时,我们将试图通过脑-肠轴来确认 TEAS 的作用机制。
方法/设计:这是一项前瞻性、单中心、双臂、随机对照试验,将在一家综合医院进行。共有 280 例接受腹部手术的患者按手术类型(即胃或结直肠手术)分层,并随机分为两组治疗。实验组将在 L14 和 PC6、ST36 和 ST37 接受 TEAS 刺激。假手术组将在假穴位接受假性 TEAS。主要结局是通过听诊首次肠鸣音的时间。次要结局包括肛门排气、排便恢复时间、围手术期脑肠肽的变化、术后疼痛、围手术期并发症和住院时间。
本研究结果将表明,连续预防性应用 TEAS 可改善腹部手术患者的胃肠功能恢复,这种作用可能通过脑-肠肽发挥。
中国临床试验注册中心,ChiCTR1900023263。于 2019 年 5 月 11 日注册。