Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Ileus
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Fast-track program

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Simon S. M. Ng, MD; Phone Number: (852) 2632 1495; Email: simonng@surgery.cuhk.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Sub-Investigator: Tony WC Mak, MD
    • Contact: Tony WC Mak, MD; Phone Number: (852) 2632 1495; Email: tonymak@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture; 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.	Procedure: Electroacupuncture
Active Comparator: Fast-track program; 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.	Procedure: Fast-track program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to defecation	Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first passing flatus reported by the patients		Up to 1 month
Time that the patients tolerated solid diet		Up to 1 month
Time to walk independently		Up to 1 month
Readmission rate		Up to 1 month
Total postoperative hospital stay	Including hospital stay of patients who are readmitted within 30 days after surgery.	Up to 1 month
Pain scores on visual analog scale	From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.	Up to 1 month
Morbidity		Up to 1 month
Mortality		Up to 1 month
Quality of life	Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires	Up to 1 month

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Simon S. M. Ng, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Randomized controlled trial; Colorectal surgery; Electroacupuncture; Hospital stay; Postoperative ileus; Fast track program
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: CRE-2013.009