Effects of acupuncture treatment on postoperative gastrointestinal dysfunction in colorectal cancer: study protocol for randomized controlled trials

BACKGROUND: Postoperative gastrointestinal dysfunction (PGID) is a common complication arising from colorectal cancer surgery. Attributing factors, such as anesthesia, surgical retraction, and early intake of water, can inhibit gastrointestinal motility, causing constipation, reduction or absence of bowel 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 postoperative 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: The study design is a prospective randomized controlled trial (RCT). One hundred sixty 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 the acupuncture group (AG) (n = 80) or control group (CG) (n = 80). AG will receive acupuncture treatment and perioperative care guided by ERAS protocols, and CG will only receive perioperative care guided by ERAS protocols. The 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 the time of first postoperative defecation, time of first fluid intake, time of first ambulation, postoperative hospital stay, gastrointestinal reaction score, acupuncture sensation evaluation scale, laboratory tests, postoperative quality of life, readmission rate, and postoperative complications. 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 the 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. Registered on August 22, 2020