Background: Postoperative gastrointestinal dysfunction is one of the common complications after surgery. At present, there has no internationally recognized acupuncture program although it has a positive effect on the recovery of postoperative gastrointestinal function. In this report, we have designed a scientific trial protocol to analyze the feasibility of applying acupuncture to gastrointestinal dysfunction after laparoscopic surgery. We intend to conduct a randomized controlled trial based on this protocol to evaluate the efficacy and safety of the acupuncture for postoperative gastrointestinal dysfunction.
Method / design: This study is a randomized, evaluator blinded, controlled, multi-center clinical trial, which has been designed according to the Consolidated Standards of Reporting Trials (CONSORT 2010) and the standard for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). The subjects will be chosen from the inpatients who have undergone laparoscopic surgery of Mianyang Hospital Affiliated to Chengdu University of traditional Chinese medicine, Mianyang Third People's Hospital and Mianyang Anzhou District People's Hospital. According to the random number generated by SPSS 25.0 software, the qualified subjects will be randomly assigned to the experimental group, the control group, and the blank group. Therapies will be performed 30 minutes after operation, the experimental group will be treated with acupuncture, the control group will be treated with intravenous injection of granisetron, and the blank group will be treated with intravenous injection of physiological saline. The main outcome is the first time of flatus after operation, and the secondary outcomes are abdominal pain, abdominal distention, nausea, vomiting times, gastrointestinal hormone level, and mental state. We will also evaluate the efficacy and safety of acupuncture on the basis of the principle of good clinical practice (GCP).
Discuss: This is a standardized and scientific clinical trial to evaluate the efficacy and safety of acupuncture for gastrointestinal dysfunction after laparoscopic surgery. Our goal is to provide objective evidence and improve the acupoint prescription in clinical practice, so as to promote the clinical application of this technology. Trial registration China clinical trial registration ID: CHICTR -1800016991. Registered on 6 July 2018.Discussion