Effects of Acupuncture Treatment on Postoperative Gastrointestinal Dysfunction in Colorectal Cancer: Study Protocol for Randomized Controlled Trials

Abstract

\n Background: Postoperative Gastrointestinal Dysfunction (PGID) is a common complication arising from colorectal cancer surgery. Attributing factors such as anesthesia, surgical retraction, early intake of water, etc. can inhibit gastrointestinal motility, causing constipation, reduction or absence of bowels sounds, nausea, vomiting and other symptoms. Delayed recovery in gastrointestinal function can lead to intestinal obstructions or paralysis, anastomotic leaks and other complications, affecting the patient’s recovery and quality of life negatively. Due to its complex pathophysiology, treatment for PGID in colorectal patients has remained a challenge. Acupuncture is an alternative therapy commonly used for post-operative recovery. This study aims to evaluate the therapeutic efficacy and safety of Acupuncture on PGID. Through the complementation of Acupuncture and Enhanced Recovery After Surgery (ERAS) protocols, the advantages of acupuncture treatments could be demonstrated to promote its application in future clinical practice.Methods/design: The study design is a prospective randomized controlled trial (RCT). 160 postoperative colorectal cancer patients will be recruited from Cancer Hospital Chinese Academy of Medical Sciences (CICAMS). Subjects who fulfill inclusion criteria will be randomly assigned into Acupuncture group (AG)(n=80) or control group (CG)(n=80). AG will receive Acupuncture treatment and ERAS care protocols, CG will only receive ERAS care protocols. Intervention will begin on the first day post-surgery, continuing for 4 days, with a follow-up assessment in a month. Time of first postoperative flatus would be the primary outcome measure. Secondary outcome measures include time of first postoperative defecation, time of first fluid intake, time of first ambulation, postoperative hospital stay, gastrointestinal reaction score, postoperative quality of life, acupuncture sensation evaluation scale. All results are evaluated from baseline, post-treatment and upon follow-up. Discussion: The results of the study would help elucidate evidence of the therapeutic effects of acupuncture on recovery of postoperative gastrointestinal function. The objective of the study aims for the eventual inclusion of acupuncture in the ERAS protocol, allowing for wider application in clinical practice.Trial Registration: Clinicaltrials.gov: ChiCTR2000036351. Register August 22,2020.