Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Phase 3

• Conditions: Postoperative Ileus
• Interventions: Procedure: Electroacupuncture; Procedure: Fast-track program

• Registration Number: NCT02059603
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Last Update Submitted: 2014-02-10
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	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.
Fast-track program	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.

Primary Outcome Measures

Name	Time	Method
Time to defecation	Up to 1 month	Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.

Secondary Outcome Measures

Name	Time	Method
Total postoperative hospital stay	Up to 1 month	Including hospital stay of patients who are readmitted within 30 days after surgery.
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
Pain scores on visual analog scale	Up to 1 month	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.
Morbidity	Up to 1 month
Mortality	Up to 1 month
Readmission rate	Up to 1 month
Quality of life	Up to 1 month	Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China