Gan Huachan, Lin Jinxuan, Jiang Zhi, Chen Qicheng, Cao Lixing, Chen Zhiqiang
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Trials. 2018 Feb 27;19(1):146. doi: 10.1186/s13063-018-2484-z.
Most patients who undergo abdominal surgery recover bowel movements within a week; however, some suffer prolonged intestinal paralysis or postoperative ileus (POI) leading to complications, such as infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. Chinese medicine is effective for accelerating the recovery of gastrointestinal function after abdominal surgery. Xiangbin prescription (XBP) is the standard prescription for this purpose in our hospital; however, randomized controlled trials of it have not yet been conducted.
METHODS/DESIGN: This double-blind, randomized controlled clinical trial aims to recruit patients who have undergone abdominal surgery and experienced postoperative dysmotility to evaluate the efficacy and safety of XBP for preventing POI and accelerating recovery. The research will tackle the common problem of slow recovery of gastrointestinal function after surgery. The participants will be patients who undergo laparoscopic radical resection of rectal carcinoma or laparoscopic panhysterectomy of a benign lesion. Primary outcome measures will be time to first flatus, defecation, normal bowel sounds, and liquid/semi-liquid/general diet. Good Clinical Practice (GCP) standards of efficacy and safety will also be evaluated, along with objective investigation of the mechanism of action of ghrelin.
This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of XBP for the recovery of gastrointestinal function after surgery, and it will conform to international standards for clinical trials for the recognition of traditional Chinese medicine.
Chinese Clinical Trial Registry, ID: ChiCTR-TRC-14004156 . Registered on 3 January 2014.
大多数接受腹部手术的患者在一周内恢复肠道蠕动；然而，一些患者会遭受长时间的肠道麻痹或术后肠梗阻（POI），从而导致感染和肠粘连等并发症，这可能会延长住院时间并增加再入院率，进而增加医疗成本。中药对加速腹部手术后胃肠功能的恢复有效。香滨方（XBP）是我院用于此目的的标准方剂；然而，尚未对其进行随机对照试验。
方法/设计：这项双盲、随机对照临床试验旨在招募接受腹部手术并经历术后运动障碍的患者，以评估XBP预防POI和加速恢复的疗效和安全性。该研究将解决术后胃肠功能恢复缓慢这一常见问题。参与者将是接受直肠癌腹腔镜根治性切除术或良性病变腹腔镜全子宫切除术的患者。主要结局指标将是首次排气、排便、肠鸣音正常以及流食/半流食/普通饮食的时间。还将评估疗效和安全性的良好临床实践（GCP）标准，以及对胃饥饿素作用机制的客观研究。
这项关键试验将是一项标准化、科学性的临床试验，旨在评估XBP用于术后胃肠功能恢复的情况，并且将符合认可中药的国际临床试验标准。
中国临床试验注册中心，标识符：ChiCTR-TRC-14004156。于2014年1月3日注册。
