NCT03222557

Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Ileus
• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Electroacupuncture	Refer to arm description
PROCEDURE	Sham Acupuncture	Refer to arm description
DEVICE	Electroacupuncture	Refer to arm description
DEVICE	Sham Acupuncture	Refer to arm description

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-07-19
• Last updated: 2017-10-06

Locations

1 site across 1 country: Hong Kong