Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

NCT00464425 | Completed Phase 3 DMC

• 1 other identifier: CRE-2006.429-T
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. In fact, a substantial portion of the overall hospitalisation period after colorectal surgery is attributed to the time it takes for ileus to resolve. Although laparoscopic colorectal surgery has been proven to be associated with better short-term clinical outcomes including faster return of gastrointestinal function than open surgery, the duration of postoperative ileus in the laparoscopic arm is still reported to be as long as 4 days in most of the randomised trials. Additional measures are thus necessary to further enhance the gastrointestinal recovery after laparoscopic colorectal surgery in order to maximise its benefits, and acupuncture may be one of the options. Acupuncture is widely accepted in China as well as throughout the world as an effective treatment option for the management of postoperative nausea and vomiting and various functional gastrointestinal disorders. Its role in treating postoperative ileus, however, is less clear, and data from the Chinese as well as the Western literature are scarce. We therefore propose to carry out a prospective randomised sham-controlled pilot study to assess the efficacy of electroacupuncture in treating postoperative ileus after laparoscopic colorectal surgery. The acupoints relevant to the treatment of 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.

Conditions

Postoperative Ileus

Keywords

Electroacupuncture; Postoperative ileus; Colorectal surgery; Laparoscopic surgery; Randomised trial

Outcome Measures

Primary Outcomes (1)

• Time to defaecation, measured in days, from the time the laparoscopic surgery ends till the first observed passage of stool

  Up to 1 month

Secondary Outcomes (6)

• Time of first passing flatus reported by the patients (days)

  Up to 1 month

• Time to resume normal diet (days)

  Up to 1 month

• Time to walk independently (days)

  Up to 1 month

• Duration of hospital stay (days)

  Up to 1 month

• Pain scores on visual analogue scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable) on the first 3 postoperative days

  Up to 1 month

Study Arms (3)

Electroacupuncture (EA)

EXPERIMENTAL

EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles

Procedure: Electroacupuncture

Sham Acupuncture (SA)

SHAM COMPARATOR

Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used

Procedure: Sham Acupuncture

No Acupuncture (NA)

NO INTERVENTION

Control

Other: No Acupuncture

Interventions

Electroacupuncture PROCEDURE

EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles

Also known as: EA

Electroacupuncture (EA)

Sham Acupuncture PROCEDURE

Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used

Also known as: SA

Sham Acupuncture (SA)

No Acupuncture OTHER

Control

No Acupuncture (NA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without the need of conversion
• Patients with American Society of Anaesthesiologists grading I-III
• Informed consent available

You may not qualify if:

• Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, and total/proctocolectomy
• Patients undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases (e.g. liver metastasis, symptomatic gallstones)
• Patients undergoing laparoscopic resection of colorectal cancer with en-bloc resection of surrounding organs (e.g. small bowel, urinary bladder)
• Patients who developed intraoperative problems or complications (e.g. bleeding, tumour perforation) that required conversion
• Patients with intestinal obstruction
• Patients with previous history of abdominal surgery
• Patients with stoma creation
• Patients with evidence of peritoneal carcinomatosis
• Patients who are expected to receive epidural opioids for postoperative pain management
• Patients who are allergic to acupuncture needles

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Surgical Wards 4C and 4D, Prince of Wales Hospital, Shatin

Hong Kong SAR, China

Location

Related Publications (1)

• Ng SSM, Leung WW, Mak TWC, Hon SSF, Li JCM, Wong CYN, Tsoi KKF, Lee JFY. Electroacupuncture reduces duration of postoperative ileus after laparoscopic surgery for colorectal cancer. Gastroenterology. 2013 Feb;144(2):307-313.e1. doi: 10.1053/j.gastro.2012.10.050. Epub 2012 Nov 6.

  PMID: 23142625 DERIVED

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 SM Ng, FRCSEd (Gen)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 21, 2011

Record last verified: 2011-04

Locations

CN (1)