Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

NCT02059603 | Unknown Phase 3

• 1 other identifier: CRE-2013.009
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Keywords

Electroacupuncture; Fast track program; Postoperative ileus; Laparoscopic surgery; Colorectal surgery; Randomized controlled trial; Hospital stay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Total postoperative hospital stay

  Up to 1 month

• 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

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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

Fast-track program

ACTIVE COMPARATOR

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

Interventions

Electroacupuncture PROCEDURE

Electroacupuncture

Fast-track program PROCEDURE

Fast-track program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Simon S. M. Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon S. M. Ng, MD

CONTACT

(852) 2632 1495; simonng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

CN (1)