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

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ClinicalTrials.gov Identifier: NCT04090073
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Time to defecation [ Time Frame: Up to 1 month ]
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2019)
  • Total postoperative hospital stay [ Time Frame: Up to 1 month ]
    Including hospital stay of patients who are readmitted within 30 days after surgery
  • Time of first passing flatus reported by the patients [ Time Frame: Up to 1 month ]
  • Time that the patients tolerated solid diet [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
  • Pain scores on visual analog scale [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
    Defined by the Clavien-Dindo classification of surgical complications
  • Incidence rate of adverse events related to electroacupuncture [ Time Frame: Up to 1 month ]
  • Readmission rate [ Time Frame: Up to 1 month ]
  • Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Total postoperative hospital stay [ Time Frame: Up to 1 month ]
    Including hospital stay of patients who are readmitted within 30 days after surgery
  • Time of first passing flatus reported by the patients [ Time Frame: Up to 1 month ]
  • Time that the patients tolerated solid diet [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
  • Pain scores on visual analog scale [ Time Frame: Up to 1 month ]
    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 [ Time Frame: Up to 1 month ]
    Defined by the Clavien-Dindo classification of surgical complications
  • Incidence rate of adverse events related to electroacupuncture [ Time Frame: Up to 1 month ]
  • Readmission rate [ Time Frame: Up to 1 month ]
  • Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery [ Time Frame: Up to 1 month ]
  • 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 [ Time Frame: Up to 1 month ]
  • Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery [ Time Frame: Up to 1 month ]
  • Direct/indirect medical costs and out-of-hospital economic costs [ Time Frame: Up to 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Official Title  ICMJE Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Ileus
Intervention  ICMJE
  • Procedure: Electroacupuncture
    As above
  • Other: Fast-track Perioperative program
    As above
Study Arms  ICMJE
  • Experimental: Electroacupuncture Plus Fast-track Perioperative Program
    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.
    Interventions:
    • Procedure: Electroacupuncture
    • Other: Fast-track Perioperative program
  • Active Comparator: Fast-track Perioperative Program
    Patients who are randomized to the control arm will receive Fast-track program alone.
    Intervention: Other: Fast-track Perioperative program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Simon SM Ng, MD +852-35051495 simonng@surgery.cuhk.edu.hk
Contact: Tony WC Mak, MD +852-35051495 tonymak@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090073
Other Study ID Numbers  ICMJE CREC 2017.668-T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simon S. M. Ng, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP