Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

• ClinicalTrials.gov Identifier: NCT00464425
• Recruitment Status: Completed
• First Posted: April 23, 2007
• Last Update Posted: April 21, 2011
• Sponsor: Chinese University of Hong Kong
• Information provided by: Chinese University of Hong Kong

Tracking Information

• First Submitted Date: April 20, 2007
• First Posted Date: April 23, 2007
• Last Update Posted Date: April 21, 2011
• Study Start Date: October 2008
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 26, 2010): Time to defaecation, measured in days, from the time the laparoscopic surgery ends till the first observed passage of stool [ Time Frame: Up to 1 month ]
• Original Primary Outcome Measures (submitted: April 20, 2007): Time to defaecation, measured in days, from the time the laparoscopic surgery ends till the first observed passage of stool

Current Secondary Outcome Measures (submitted: April 26, 2010)

• Time of first passing flatus reported by the patients (days) [ Time Frame: Up to 1 month ]
• Time to resume normal diet (days) [ Time Frame: Up to 1 month ]
• Time to walk independently (days) [ Time Frame: Up to 1 month ]
• Duration of hospital stay (days) [ Time Frame: 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 [ Time Frame: Up to 1 month ]
• Postoperative analgesic requirement (number of doses on 50-mg Pethidine). [ Time Frame: Up to 1 month ]

Original Secondary Outcome Measures (submitted: April 20, 2007)

• Time of first passing flatus reported by the patients (days)
• Time to resume normal diet (days)
• Time to walk independently (days)
• Duration of hospital stay (days)
• 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
• Postoperative analgesic requirement (number of doses on 50-mg Pethidine).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery
• Official Title: Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery: a Randomised Sham-controlled Pilot Study
• 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.

Detailed Description

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. Different treatment modalities including thoracic epidural analgesia, pharmacological therapy, early enteral feeding, and early mobilisation have been attempted, but none has an established role as a specific remedy for postoperative ileus. 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 (which is just about 1 day earlier than that in the open arm) 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. Besides, the heterogeneity of the study designs and flaws in methodology of the reported studies have made interpretation of these data difficult. Results of the present study can provide evidence-based clarification of the role of acupuncture in treating postoperative ileus after laparoscopic colorectal surgery. If the hypothesis is proven to be correct and substantiated by further studies, the incorporation of electroacupuncture into any fast-track recovery programmes after laparoscopic, open, or even emergency colorectal surgery should be considered. As laparoscopic colorectal surgery has been shown to have higher direct cost than the open counterpart, a faster postoperative recovery may help to reduce the financial burden to the hospital and improve the cost-effectiveness of the procedure.

Patients will be enrolled into the study if all the inclusion and exclusion criteria are satisfied after the laparoscopic surgery. Randomisation will be done shortly after surgery. Patients will be randomised to receive either electroacupuncture (EA group), sham acupuncture (SA group), or no acupuncture (NA group). The medical acupuncturist is the only individual who is aware of the treatment allocation; patients of the EA and SA groups are blinded to the treatment. The patients randomised to the EA and SA groups will undergo 1 session of acupuncture daily from postoperative day 1 till day 4. Adverse events associated with acupuncture including bleeding, dizziness, excessive pain, and allergic reaction will be closely monitored. The acupuncture needle will be immediately withdrawn if these events occur.

The postoperative management of all patients will be standardised. Pethidine 1mg/kg as postoperative analgesia will be given every 4-hourly on demand. Early ambulation will be encouraged. Oral feeding will be resumed as soon as gastrointestinal function returns clinically (no nausea or vomiting, no abdominal distension, passage of flatus or stool). No gum chewing will be allowed. Patients will be discharged when they tolerate diet and are fully ambulatory.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Postoperative Ileus

Intervention

• Procedure: Electroacupuncture
  EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
  Other Name: EA
• Procedure: Sham Acupuncture
  Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
  Other Name: SA
• Other: No Acupuncture
  Control

Study Arms

• Experimental: Electroacupuncture (EA)
  EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
  Intervention: Procedure: Electroacupuncture
• Sham Comparator: Sham Acupuncture (SA)
  Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
  Intervention: Procedure: Sham Acupuncture
• No Intervention: No Acupuncture (NA)
  Control
  Intervention: Other: No Acupuncture

• Publications *: Ng SS, Leung WW, Mak TW, Hon SS, Li JC, Wong CY, Tsoi KK, Lee JF. 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 26, 2010): 165
• Original Enrollment (submitted: April 20, 2007): 150
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00464425
• Other Study ID Numbers: CRE-2006.429-T
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Simon SM Ng, The Chinese University of Hong Kong
• Study Sponsor: Chinese University of Hong Kong
• Collaborators: Not Provided

Investigators

• Principal Investigator: Simon SM Ng, FRCSEd (Gen); Chinese University of Hong Kong

• PRS Account: Chinese University of Hong Kong
• Verification Date: April 2011