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

• Published in: BMJ open 2024-07, Vol.14 (7), p.e083460
• Main Authors: Fu, Yi-Ming, Yang, Ying-Chi, Zhang, Jing, Zhao, Jingjie, Liu, Gong-Yong, Ling, Shen, Wang, Chao, Wang, Li-Wei, Yang, Yu-Tong, Wang, Yu, Yang, Na-Na, Liu, Cun-Zhi, Pei, Wei
• Format: Article
• Language: English
• Subjects: Acupuncture; Adult; Anesthesia; China; Colorectal cancer; Colorectal Neoplasms - surgery; colorectal surgery; Complementary Medicine; Electroacupuncture; Electroacupuncture - methods; Female; gastroenterology; Hospitals; Humans; Ileus - etiology; Ileus - therapy; Informed consent; Intervention; Laparoscopy; Laparoscopy - adverse effects; Length of Stay - statistics & numerical data; Male; Medical research; Multicenter Studies as Topic; Patients; Performance evaluation; Postoperative Complications - etiology; Postoperative Complications - therapy; Preoperative Care - methods; Randomized Controlled Trials as Topic; Recovery (Medical); Substance abuse treatment; Surgery
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-083460

IntroductionPostoperative 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.Methods and analysisThis 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.Ethics and disseminationThis 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.Trial registration numberChiCTR2300077633.