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A RANDOMIZED NONINFERIORITY TRIAL OF ELECTROACUPUNCTURE VERSUS FAST-TRACK PERIOPERATIVE PROGRAM FOR REDUCING DURATION OF POSTOPERATIVE ILEUS AND HOSPITAL STAY AFTER LAPAROSCOPIC COLORECTAL SURGERY
Simon S. Ng*1, Wing Wa Leung1, Simon K. Chan2, Tony Mak1, Sophie S. Hon1, Dennis Ngo1, Simon Chu1, Oky C. Lam1, Yee Ni C. Wong1, Janet F. Lee1
1Surgery, The Chinese University of Hong Kong, Hong Kong , Hong Kong; 2Anesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Background and Objective: Ample evidence suggested that ‘fast-track’ (FT) perioperative program can reduce surgical stress and accelerate postoperative recovery after colorectal surgery. Our recent study also demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou can enhance recovery after laparoscopic colorectal surgery (Ng et al. Gastroenterology 2013; 144: 307-313). This prospective, randomized, noninferiority trial aimed to compare the efficacy of EA and FT program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Methods: Between January 2014 and March 2016, 164 patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion were randomized to receive either EA or FT program (82 per group). The primary outcome was time to defecation. Secondary outcomes were hospital stay, 30-day morbidity and readmission rates, and overall cost. Data were analyzed by intention-to-treat principle.
Results: The demographic data of the two groups were comparable. The overall protocol compliance rate in the FT group was 85%. The mean time to defecation in the EA and FT groups was 79.0 ± 42.2 hours and 72.9 ± 30.0 hours (difference = 6.1 hours; 95% confidence interval [CI], -5.2 hours to 17.5 hours), respectively (P = 0.286). Noninferiority was demonstrated as the upper limit of 95% CI for the difference was within the prespecified noninferiority margin of 24 hours. There was a trend towards shorter mean total postoperative hospital stay in the EA group (5.8 ± 2.9 days vs. 6.8 ± 5.3 days, P = 0.119). The overall 30-day morbidity rate in the EA and FT groups was similar (13.4% vs. 22.0%, P = 0.152). There was no difference in readmission rates between the two groups. The implementation cost of EA was significantly lower than the cost of implementation of the FT program (US$128 ± 46 vs. US$509 ± 13, P <0.001). The total direct cost was also lower in the EA group than in the FT group (US$15,192 ± 3,164 vs. US$17,005 ± 7,661, P = 0.049).
Conclusions: EA is noninferior to FT program in reducing the duration of postoperative ileus after laparoscopic colorectal surgery. Postoperative hospital stay and overall morbidity rate are also similar between the two perioperative management strategies. EA may be the preferred perioperative therapy for laparoscopic colorectal surgery because it is simpler to implement, less labor intensive, and less expensive than the FT program. (ClinicalTrials.gov number, NCT02059603)
This study was supported by the Health and Medical Research Fund, Food and Health Bureau, The Government of the Hong Kong SAR (Reference Number 11120121); PI: Professor Simon SM Ng.
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