Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial

Huachan Gan,Qicheng Chen,Jinxuan Lin,Zhi Jiang,Lixing Cao,Zhiqiang Chen

doi:10.1186/s13063-018-2484-z

Abstract

BackgroundMost 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/designThis 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.DiscussionThis 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.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-TRC-14004156. Registered on 3 January 2014.

Highlights

Most patients who undergo abdominal surgery recover bowel movements within a week; 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 increasing healthcare costs
This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of Xiangbin prescription (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
The adverse effects of gastrointestinal dysfunction can lead to infection and intestinal adhesions, impeding recovery of function for patients, increasing the medical burden, and prolonging hospitalization

Summary

Discussion

Surgical trauma, effects of anesthesia, the inflammatory response, carbon dioxide pneumoperitoneum, long-term postoperative bed rest, and other factors can cause postoperative gastrointestinal dysfunction in abdominal surgery patients [12] and investigating this problem in patients may be important if it is severe or protracted. This study is designed to evaluate the efficacy and safety of the Chinese medicine, XBP, for the treatment of postoperative gastrointestinal dysfunction in abdominal surgery patients, and to provide a scientific basis for use of this medicine. A prospective, clinical [18], randomized, single-blind, placebo-controlled trial conducted in our hospital proved that XBP can effectively promote the recovery of gastrointestinal function after transabdominal gynecological surgery. 2. Features of this study protocol (1) the study is designed as a double-blind, randomized controlled, clinical, pivotal trial, which is recognized as the most conclusive research method for therapeutic evaluation; (2) since the majority of outcome measures used to examine impacts on gastrointestinal symptoms remain uncertain, we measured gastrointestinal symptoms by combining primary and secondary outcome measures to ensure scientific objectivity; (3) before patients are enrolled in the study, practitioners will be required to explain the procedure in detail, including the nature, purpose, potential benefits and risks, the rights and obligations of the subject, and the alternative treatments, etc.

Background