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Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02059603
Recruitment Status : Unknown
Verified February 2014 by Simon S. M. Ng, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Procedure: Electroacupuncture Procedure: Fast-track program Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electroacupuncture
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.
Procedure: Electroacupuncture
Active Comparator: Fast-track program
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.
Procedure: Fast-track program



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total postoperative hospital stay [ Time Frame: Up to 1 month ]
    Including hospital stay of patients who are readmitted within 30 days after surgery.

  2. Time of first passing flatus reported by the patients [ Time Frame: Up to 1 month ]
  3. Time that the patients tolerated solid diet [ Time Frame: Up to 1 month ]
  4. Time to walk independently [ Time Frame: Up to 1 month ]
  5. 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; assessed at 4, 12, 24, 48, and 72 hours after surgery.

  6. Morbidity [ Time Frame: Up to 1 month ]
  7. Mortality [ Time Frame: Up to 1 month ]
  8. Readmission rate [ Time Frame: Up to 1 month ]
  9. Quality of life [ Time Frame: Up to 1 month ]
    Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059603


Contacts
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Contact: Simon S. M. Ng, MD (852) 2632 1495 simonng@surgery.cuhk.edu.hk

Locations
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China
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Simon SM Ng, MD    (852) 2632 1495    simonng@surgery.cuhk.edu.hk   
Contact: Tony WC Mak, MD    (852) 2632 1495    tonymak@surgery.cuhk.edu.hk   
Principal Investigator: Simon SM Ng, MD         
Sub-Investigator: Tony WC Mak, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Simon S. M. Ng, MD Chinese University of Hong Kong

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Responsible Party: Simon S. M. Ng, Professor of Surgery, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02059603     History of Changes
Other Study ID Numbers: CRE-2013.009
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Simon S. M. Ng, Chinese University of Hong Kong:
Electroacupuncture
Fast track program
Postoperative ileus
Laparoscopic surgery
Colorectal surgery
Randomized controlled trial
Hospital stay

Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases