Rectal Cancer Clinical Trial
Official title:
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer: A Prospective, Randomized, Sham-controlled Trial
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.
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