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Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01844908
First received: April 24, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Postoperative Ileus
Procedure: Electroacupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Electroacupuncture Prevent Prolonged Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer? A Prospective Study With Matched Historical Controls

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Incidence of prolonged ileus [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    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 Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Time to first defecation [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Time that the patients tolerated solid diet [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Pain scores on visual analog scale [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    From 0 which implies no pain at all, to 10 which implies the worst pain imaginable

  • Postoperative analgesic requirement [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Overall complication rate [ Time Frame: Up to 1 month ] [ Designated as safety issue: Yes ]
  • 30-day mortality rate [ Time Frame: Up to 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electroacupuncture Procedure: Electroacupuncture

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844908

Contacts
Contact: Simon SM Ng, MD (852)26321495 simonng@surgery.cuhk.edu.hk
Contact: Wing Wa Leung, MSc (852)26321495 leungww@surgery.cuhk.edu.hk

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong SAR, China
Contact: Simon SM Ng, MD    (852)26321495    simonng@surgery.cuhk.edu.hk   
Contact: Wing Wa Leung, MSc    (852)26321495    leungww@surgery.cuhk.edu.hk   
Principal Investigator: Simon SM Ng, MD         
Sub-Investigator: Wing Wa Leung, MSc         
Sub-Investigator: Tony WC Mak, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01844908     History of Changes
Other Study ID Numbers: CRE-2013.032
Study First Received: April 24, 2013
Last Updated: February 10, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014