Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Last updated: February 10, 2014
Sponsor: Chinese University of Hong Kong
Overall Status: Trial Status Unknown

Phase

3

Condition

Ileus

Treatment

N/A

Clinical Study ID

NCT02059603
CRE-2013.009
  • Ages 18-80
  • All Genders

Study Summary

Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Design: Prospective, randomized, noninferiority trial.

Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.

Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.

Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.

Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive patients undergoing elective laparoscopic resection of colonic and upperrectal cancer

  • Age of patients between 18 and 80 years

  • Patients with American Society of Anesthesiologists (ASA) grading I-II

  • Patients with no severe physical disability

  • Patients who require no assistance with the activities of daily living

  • Informed consent available

Exclusion

Exclusion Criteria:

  • Patients undergoing laparoscopic low anterior resection with total mesorectalexcision, abdominoperineal resection, or total/proctocolectomy

  • Patients with planned stoma creation

  • Patients undergoing emergency surgery

  • Patients with evidence of peritoneal carcinomatosis

  • Patients with previous history of midline laparotomy

  • Patients who are expected to receive epidural opioids for postoperative painmanagement

  • Patients with cardiac pacemaker

  • Patients who are allergic to the acupuncture needles

Study Design

Total Participants: 164
Study Start date:
January 01, 2014
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Prince of Wales Hospital, The Chinese University of Hong Kong

    Hong Kong,
    China

    Active - Recruiting

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