This is a prospective, randomized, sham-controlled, superiority trial that aimed to investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal resection for rectal cancer.
Background: Postoperative ileus (POI) remains a significant problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. The investigators' previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of POI and hospital stay after laparoscopic resection of colonic and upper rectal cancer (Ng et al. Gastroenterology 2013; 144: 307-313). However, patients with mid/low rectal cancer undergoing laparoscopic sphincter-preserving total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. These complicated cases are apparently more likely to develop prolonged ileus and morbidity after surgery. Objectives: To investigate the efficacy of EA in reducing the duration of POI and hospital stay after laparoscopic TME or APR for rectal cancer. Hypothesis: Rectal cancer patients undergoing laparoscopic TME or APR within a fast-track perioperative program who receive EA will have shorter duration of POI and hospital stay when compared with those who receive sham acupuncture (SA). Design: Prospective, randomized, sham-controlled, superiority trial. Subjects: One hundred and sixty four consecutive patients with mid/low rectal cancer undergoing laparoscopic surgery without the need of conversion will be recruited. All patients will follow a standard perioperative fast-track program. Interventions: Patients will be randomly allocated to receive either EA or SA. Bilateral acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou will be used. The acupuncturist is the only individual who is aware of the treatment allocation; the patients randomized to the EA/SA groups and the outcome assessor are blinded to the treatment allocation. The patients will undergo one session of EA daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier. Outcome measures: Primary outcome: a composite endpoint of time to recovery of upper and lower gastrointestinal function (GI-2). Secondary outcomes: time to discharge order written, length of hospital stay, postoperative pain scores and analgesic requirement, and postoperative 30-day morbidity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
164
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Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGGI-2 recovery
A composite assessment that measured upper (first tolerance of solid food) and lower (first bowel movement) GI tract recovery, with time to achieve GI-2 recovery based on the last event to occur
Time frame: Up to 10 days
Time of first passing flatus
Time frame: Up to 10 days
Length of hospital stay
Time frame: Up to 1 month
Pain scores on the first 3 postoperative days
On visual analog scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable)
Time frame: Up to postoperative day 3
Postoperative analgesic requirement
Time frame: Up to 1 month
Short-term morbidity
Defined by the Clavien-Dindo classification of surgical complications
Time frame: Up to 1 month
Adverse events related to EA/SA
Time frame: Up to 1 month
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