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Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Primary Purpose

Postoperative Ileus

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Fast-track program
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, Fast track program, Postoperative ileus, Laparoscopic surgery, Colorectal surgery, Randomized controlled trial, Hospital stay

Eligibility Criteria

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

Inclusion Criteria:

  • Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer
  • Age of patients between 18 and 80 years
  • Patients with American Society of Anesthesiologists (ASA) grading I-II
  • Patients with no severe physical disability
  • Patients who require no assistance with the activities of daily living
  • Informed consent available

Exclusion Criteria:

  • Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy
  • Patients with planned stoma creation
  • Patients undergoing emergency surgery
  • Patients with evidence of peritoneal carcinomatosis
  • Patients with previous history of midline laparotomy
  • Patients who are expected to receive epidural opioids for postoperative pain management
  • Patients with cardiac pacemaker
  • Patients who are allergic to the acupuncture needles

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electroacupuncture

Fast-track program

Arm Description

Bilateral acupoints relevant to the treatment of abdominal pain, 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. Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles.

The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.

Outcomes

Primary Outcome Measures

Time to defecation
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.

Secondary Outcome Measures

Total postoperative hospital stay
Including hospital stay of patients who are readmitted within 30 days after surgery.
Time of first passing flatus reported by the patients
Time that the patients tolerated solid diet
Time to walk independently
Pain scores on visual analog scale
From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.
Morbidity
Mortality
Readmission rate
Quality of life
Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires

Full Information

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

Unique Protocol Identification Number
NCT02059603
Brief Title
Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Official Title
A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (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
Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Design: Prospective, randomized, noninferiority trial. Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited. Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture. Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs. Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Electroacupuncture, Fast track program, Postoperative ileus, Laparoscopic surgery, Colorectal surgery, Randomized controlled trial, Hospital stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
Bilateral acupoints relevant to the treatment of abdominal pain, 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. Electric stimulation at a frequency of 50 Hz will be employed to the acupuncture needles.
Arm Title
Fast-track program
Arm Type
Active Comparator
Arm Description
The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Type
Procedure
Intervention Name(s)
Fast-track program
Primary Outcome Measure Information:
Title
Time to defecation
Description
Measured in hours, 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
Total postoperative hospital stay
Description
Including hospital stay of patients who are readmitted within 30 days after surgery.
Time Frame
Up to 1 month
Title
Time of first passing flatus reported by the patients
Time Frame
Up to 1 month
Title
Time that the patients tolerated solid diet
Time Frame
Up to 1 month
Title
Time to walk independently
Time Frame
Up to 1 month
Title
Pain scores on visual analog scale
Description
From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.
Time Frame
Up to 1 month
Title
Morbidity
Time Frame
Up to 1 month
Title
Mortality
Time Frame
Up to 1 month
Title
Readmission rate
Time Frame
Up to 1 month
Title
Quality of life
Description
Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
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 undergoing elective laparoscopic resection of colonic and upper rectal cancer Age of patients between 18 and 80 years Patients with American Society of Anesthesiologists (ASA) grading I-II Patients with no severe physical disability Patients who require no assistance with the activities of daily living Informed consent available Exclusion Criteria: Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy Patients with planned stoma creation Patients undergoing emergency surgery Patients with evidence of peritoneal carcinomatosis Patients with previous history of midline laparotomy Patients who are expected to receive epidural opioids for postoperative pain management Patients with cardiac pacemaker Patients who are allergic to the acupuncture needles
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon S. M. Ng, MD
Phone
(852) 2632 1495
Email
simonng@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon S. M. 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
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
Phone
(852) 2632 1495
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Tony WC Mak, MD
Phone
(852) 2632 1495
Email
tonymak@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
First Name & Middle Initial & Last Name & Degree
Tony WC Mak, MD

12. IPD Sharing Statement

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Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

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