Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

NCT ID: NCT02059603

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Fast-track program

Intervention Type: PROCEDURE

Interventions

Electroacupuncture

Intervention Type: PROCEDURE

Fast-track program

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon S. M. Ng

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon S. M. Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Simon S. M. Ng, MD

Role: CONTACT

simonng@surgery.cuhk.edu.hk

(852) 2632 1495

Facility Contacts

Simon SM Ng, MD

Role: primary

simonng@surgery.cuhk.edu.hk

(852) 2632 1495

Tony WC Mak, MD

Role: backup

tonymak@surgery.cuhk.edu.hk

(852) 2632 1495

Other Identifiers

CRE-2013.009

Identifier Type: -

Identifier Source: org_study_id