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Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Primary Purpose

Postoperative Ileus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Fast-track Perioperative 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

Eligibility Criteria

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

Inclusion Criteria:

  • Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy)
  • Age of patients >18 years
  • Those with American Society of Anesthesiologists (ASA) grading I-III
  • Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30)
  • Those with no severe physical disability
  • Those 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; those with planned stoma creation
  • Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases
  • Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs
  • Those who developed intraoperative problems or complications that required conversion
  • Those undergoing emergency surgery
  • Those with evidence of peritoneal carcinomatosis
  • Those with previous history of midline laparotomy
  • Those who are expected to receive epidural opioids for postoperative pain management
  • Those who are pregnant
  • Those with cardiac pacemaker
  • Those with coagulopathy
  • Those 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 Plus Fast-track Perioperative Program

Fast-track Perioperative Program

Arm Description

Patients who are randomized to the intervention arm will receive Electroacupuncture combined with Fast-track program. Each session of Electroacupuncture will last for 20 minutes. The patients will undergo one session of Electroacupuncture daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier.

Patients who are randomized to the control arm will receive Fast-track program alone.

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 that the patients tolerated solid diet (any food that required chewing) without vomiting or experiencing significant nausea 4 hours following the meal
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, on the first 3 postoperative days
Postoperative 30-day morbidity
Defined by the Clavien-Dindo classification of surgical complications
Incidence rate of adverse events related to electroacupuncture
Readmission rate
Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery
SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery
EORTC QLQ-C30 is a generic questionnaire for assessment of quality of life (QoL) in cancer patients. It includes 30 items, 24 of which are combined to form a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and three symptom scales (fatigue, nausea/vomiting, and pain). The other six single items evaluate dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery
EORTC QLQ-CR38 is a specific questionnaire module specifically designed for assessment of quality of life (QoL) in patients with colorectal cancer. It consists of 38 items covering symptoms and side effects related to different colorectal cancer treatment modalities. The module contains four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and eight symptom scales/items (micturition problems, chemotherapy side effects, gastrointestinal tract symptoms, male sexual problems, female sexual problems, defecation problems, stoma-related problems, and weight loss). All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Direct/indirect medical costs and out-of-hospital economic costs

Full Information

First Posted
September 12, 2019
Last Updated
October 2, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04090073
Brief Title
Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Official Title
Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: The investigators' previous study demonstrated that electroacupuncture (EA) 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' (FT) perioperative program may help accelerate recovery after colorectal surgery. It is uncertain whether the combination of EA and FT program will result in faster recovery after laparoscopic colorectal surgery when compared with FT program alone. Objectives: To compare the efficacy of EA combined with FT program versus FT program alone in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery Design: Prospective randomized trial. Subjects: 72 consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion will be recruited. Interventions: Patients will be randomly allocated to one of the two groups receiving either EA + FT program, or FT program alone. Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time to resume diet, pain scores, analgesic requirement, morbidity, quality of life, and medical costs. Conclusions: This study serves as a good example that illustrates an integrated approach in combining Chinese and Western models of health care. It will provide evidence-based clarification of the role of EA in enhancing recovery after laparoscopic colorectal surgery within a FT perioperative care setting. As laparoscopic colorectal surgery has been shown to have a higher direct cost than the open counterpart, a faster postoperative recovery may help reduce the financial burden to the hospital/healthcare system.

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture Plus Fast-track Perioperative Program
Arm Type
Experimental
Arm Description
Patients who are randomized to the intervention arm will receive Electroacupuncture combined with Fast-track program. Each session of Electroacupuncture will last for 20 minutes. The patients will undergo one session of Electroacupuncture daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier.
Arm Title
Fast-track Perioperative Program
Arm Type
Active Comparator
Arm Description
Patients who are randomized to the control arm will receive Fast-track program alone.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Description
As above
Intervention Type
Other
Intervention Name(s)
Fast-track Perioperative program
Intervention Description
As above
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
Description
Time that the patients tolerated solid diet (any food that required chewing) without vomiting or experiencing significant nausea 4 hours following the meal
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, on the first 3 postoperative days
Time Frame
Up to 1 month
Title
Postoperative 30-day morbidity
Description
Defined by the Clavien-Dindo classification of surgical complications
Time Frame
Up to 1 month
Title
Incidence rate of adverse events related to electroacupuncture
Time Frame
Up to 1 month
Title
Readmission rate
Time Frame
Up to 1 month
Title
Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery
Description
SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Up to 1 month
Title
Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery
Description
EORTC QLQ-C30 is a generic questionnaire for assessment of quality of life (QoL) in cancer patients. It includes 30 items, 24 of which are combined to form a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and three symptom scales (fatigue, nausea/vomiting, and pain). The other six single items evaluate dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Time Frame
Up to 1 month
Title
Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery
Description
EORTC QLQ-CR38 is a specific questionnaire module specifically designed for assessment of quality of life (QoL) in patients with colorectal cancer. It consists of 38 items covering symptoms and side effects related to different colorectal cancer treatment modalities. The module contains four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and eight symptom scales/items (micturition problems, chemotherapy side effects, gastrointestinal tract symptoms, male sexual problems, female sexual problems, defecation problems, stoma-related problems, and weight loss). All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Time Frame
Up to 1 month
Title
Direct/indirect medical costs and out-of-hospital economic costs
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy) Age of patients >18 years Those with American Society of Anesthesiologists (ASA) grading I-III Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30) Those with no severe physical disability Those 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; those with planned stoma creation Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs Those who developed intraoperative problems or complications that required conversion Those undergoing emergency surgery Those with evidence of peritoneal carcinomatosis Those with previous history of midline laparotomy Those who are expected to receive epidural opioids for postoperative pain management Those who are pregnant Those with cardiac pacemaker Those with coagulopathy Those who are allergic to the acupuncture needles
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon SM Ng, MD
Phone
+852-35051495
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Tony WC Mak, MD
Phone
+852-35051495
Email
tonymak@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
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, MD
Phone
(852) 3505 1495
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Tony WC Mak, MD
Phone
(852) 3505 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

Plan to Share IPD
No

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Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

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