Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls

Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. The investigators previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether EA will be beneficial to them. The investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative day 1 till day 4. These patients will be compared with a matched historical control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. Secondary outcomes include time to defecation and duration of hospital stay. Results of this study will help clarify the efficacy of EA in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.

Study Overview

• Status: Unknown
• Conditions: Postoperative Ileus
• Intervention / Treatment: Procedure: Electroacupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon SM Ng, MD; Phone Number: (852)26321495; Email: simonng@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Wing Wa Leung, MSc; Phone Number: (852)26321495; Email: leungww@surgery.cuhk.edu.hk

Study Locations

• China
  • Hong Kong SAR, China
    • Recruiting
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Contact: Simon SM Ng, MD; Phone Number: (852)26321495; Email: simonng@surgery.cuhk.edu.hk
    • Contact: Wing Wa Leung, MSc; Phone Number: (852)26321495; Email: leungww@surgery.cuhk.edu.hk
    • Sub-Investigator: Wing Wa Leung, MSc
    • Sub-Investigator: Tony WC Mak, MD

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 (aged between 18 and 80) with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion
• Patients with American Society of Anesthesiologists grading I-III
• Informed consent available

Exclusion Criteria:

• Patients undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases
• Patients undergoing laparoscopic resection of rectal cancer with en-bloc resection of surrounding organs
• Patients who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion
• Patients with intestinal obstruction
• Patients with previous history of abdominal surgery
• Patients with evidence of peritoneal carcinomatosis
• Patients who are expected to receive epidural anesthesia or analgesia
• Patients with cardiac pacemaker
• Patients who are pregnant
• Patients who are allergic to acupuncture needles

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture	Procedure: Electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of prolonged ileus	Defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support.	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 to first defecation		Up to 1 month
Time that the patients tolerated solid diet		Up to 1 month
Duration of hospital stay		Up to 1 month
Pain scores on visual analog scale	From 0 which implies no pain at all, to 10 which implies the worst pain imaginable	Up to 3 days
Postoperative analgesic requirement		Up to 1 month
Overall complication rate		Up to 1 month
30-day mortality rate		Up to 1 month

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 3, 2013

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

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: CRE-2013.032