Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial
Background: 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. Discussion: 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.
基金:
Guangdong Provincial Department of Science and Technology 2014A020212278;
Chinese Medicine Bureau of Guangdong Province (2016) No. 12 20164021;
Scientific special expenditure of Guangdong Provincial Hospital of Traditional
Chinese Medicine YK2013B2N03; Science and technology planning project of
Guangzhou 2014Y2-00048; Department of Finance of Guangdong province
(2013) No. 173; Department of Finance of Guangdong province (2016) 150-9.
第一作者机构:[1]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Gan Huachan,Lin Jinxuan,Jiang Zhi,et al.Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial[J].TRIALS.2018,19:doi:10.1186/s13063-018-2484-z.
APA:
Gan, Huachan,Lin, Jinxuan,Jiang, Zhi,Chen, Qicheng,Cao, Lixing&Chen, Zhiqiang.(2018).Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial.TRIALS,19,
MLA:
Gan, Huachan,et al."Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial".TRIALS 19.(2018)