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Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham Acupuncture
No Acupuncture
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Electroacupuncture, Postoperative ileus, Colorectal surgery, Laparoscopic surgery, Randomised trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Electroacupuncture (EA)

Sham Acupuncture (SA)

No Acupuncture (NA)

Arm Description

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

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

Control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
April 20, 2007
Last Updated
April 20, 2011
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00464425
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Electroacupuncture, Postoperative ileus, Colorectal surgery, Laparoscopic surgery, Randomised trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture (EA)
Arm Type
Experimental
Arm Description
EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
Arm Title
Sham Acupuncture (SA)
Arm Type
Sham Comparator
Arm Description
Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
Arm Title
No Acupuncture (NA)
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Other Intervention Name(s)
SA
Intervention Description
Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
Intervention Type
Other
Intervention Name(s)
No Acupuncture
Intervention Description
Control
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time of first passing flatus reported by the patients (days)
Time Frame
Up to 1 month
Title
Time to resume normal diet (days)
Time Frame
Up to 1 month
Title
Time to walk independently (days)
Time Frame
Up to 1 month
Title
Duration of hospital stay (days)
Time Frame
Up to 1 month
Title
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
Title
Postoperative analgesic requirement (number of doses on 50-mg Pethidine).
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, FRCSEd (Gen)
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Wards 4C and 4D, Prince of Wales Hospital, Shatin
City
Hong Kong SAR
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23142625
Citation
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.
Results Reference
derived

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Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

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