Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

The Chinese University of Hong Kong

Status and phase: Unknown; Phase 3

Conditions: Postoperative Ileus

Treatments: Procedure: Fast-track program; Procedure: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02059603

CRE-2013.009

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal 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 criteria

• Patients undergoing laparoscopic low anterior resection with total mesorectal excision, 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 pain management
• Patients with cardiac pacemaker
• Patients who are allergic to the acupuncture needles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Electroacupuncture

Experimental group

Description:

Bilateral acupoints relevant to the treatment of abdominal pain, abdominal distension, and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian TE-6), will be used. Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles.

Treatment:

Procedure: Electroacupuncture

Fast-track program

Active Comparator group

Description:

The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.

Treatment:

Procedure: Fast-track program