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Postoperative IleusPhase 3NCT00464425

Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

A Phase 3 study testing Electroacupuncture and No Acupuncture in people with Postoperative Ileus, run by Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Postoperative Ileus
What is being tested?
Electroacupuncture and No Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
1 siteChina
Study dates
Oct 2008to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Surgical Wards 4C and 4D, Prince of Wales Hospital, Shatin

    Hong Kong SAR

Other trials in China

About this study

Official title: Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery: a Randomised Sham-controlled Pilot Study

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.

Read the 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.

Being tested
Electroacupuncture, Sham Acupuncture, No Acupuncture
Keywords
Electroacupuncture, Postoperative ileus, Colorectal surgery, Laparoscopic surgery, Randomised trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectroacupunctureProcedure or surgery

    Also called EA

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

  • Sham AcupunctureProcedure or surgery

    Also called SA

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

  • No AcupunctureOther

    Control

Study groups in NCT00464425
Study groupRoleWhat they receive
Electroacupuncture (EA)ExperimentalEA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
Receives: Procedure: Electroacupuncture
Sham Acupuncture (SA)Sham comparatorAcupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
Receives: Procedure: Sham Acupuncture
No Acupuncture (NA)No interventionControl
Receives: Other: No Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 1 month

Secondary outcomes (6)
  1. Time of first passing flatus reported by the patients (days)

    Measured: Up to 1 month

  2. Time to resume normal diet (days)

    Measured: Up to 1 month

  3. Time to walk independently (days)

    Measured: Up to 1 month

  4. Duration of hospital stay (days)

    Measured: Up to 1 month

  5. 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

    Measured: Up to 1 month

  6. Postoperative analgesic requirement (number of doses on 50-mg Pethidine).

    Measured: Up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2007 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464425
Sponsor's protocol ID
CRE-2006.429-T
Status last verified
Apr 2011
First submitted
20 Apr 2007
Last updated
21 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23142625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Electroacupuncture and No Acupuncture in people with Postoperative Ileus, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2011.

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