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Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Primary Purpose

Postoperative Ileus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electroacupuncture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time of first passing flatus reported by the patients
Time to first defecation
Time that the patients tolerated solid diet
Duration of hospital stay
Pain scores on visual analog scale
From 0 which implies no pain at all, to 10 which implies the worst pain imaginable
Postoperative analgesic requirement
Overall complication rate
30-day mortality rate

Full Information

First Posted
April 24, 2013
Last Updated
February 10, 2014
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01844908
Brief Title
Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery
Official Title
Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Primary Outcome Measure Information:
Title
Incidence of prolonged ileus
Description
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.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Time of first passing flatus reported by the patients
Time Frame
Up to 1 month
Title
Time to first defecation
Time Frame
Up to 1 month
Title
Time that the patients tolerated solid diet
Time Frame
Up to 1 month
Title
Duration of hospital stay
Time Frame
Up to 1 month
Title
Pain scores on visual analog scale
Description
From 0 which implies no pain at all, to 10 which implies the worst pain imaginable
Time Frame
Up to 3 days
Title
Postoperative analgesic requirement
Time Frame
Up to 1 month
Title
Overall complication rate
Time Frame
Up to 1 month
Title
30-day mortality rate
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon SM Ng, MD
Phone
(852)26321495
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wing Wa Leung, MSc
Phone
(852)26321495
Email
leungww@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong SAR
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
Phone
(852)26321495
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Wing Wa Leung, MSc
Phone
(852)26321495
Email
leungww@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
First Name & Middle Initial & Last Name & Degree
Wing Wa Leung, MSc
First Name & Middle Initial & Last Name & Degree
Tony WC Mak, MD

12. IPD Sharing Statement

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Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

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