- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222557
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer: A Prospective, Randomized, Sham-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Postoperative ileus (POI) remains a significant problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. The investigators' previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of POI and hospital stay after laparoscopic resection of colonic and upper rectal cancer (Ng et al. Gastroenterology 2013; 144: 307-313). However, patients with mid/low rectal cancer undergoing laparoscopic sphincter-preserving total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. These complicated cases are apparently more likely to develop prolonged ileus and morbidity after surgery.
Objectives: To investigate the efficacy of EA in reducing the duration of POI and hospital stay after laparoscopic TME or APR for rectal cancer.
Hypothesis: Rectal cancer patients undergoing laparoscopic TME or APR within a fast-track perioperative program who receive EA will have shorter duration of POI and hospital stay when compared with those who receive sham acupuncture (SA).
Design: Prospective, randomized, sham-controlled, superiority trial.
Subjects: One hundred and sixty four consecutive patients with mid/low rectal cancer undergoing laparoscopic surgery without the need of conversion will be recruited. All patients will follow a standard perioperative fast-track program.
Interventions: Patients will be randomly allocated to receive either EA or SA. Bilateral acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou will be used. The acupuncturist is the only individual who is aware of the treatment allocation; the patients randomized to the EA/SA groups and the outcome assessor are blinded to the treatment allocation. The patients will undergo one session of EA daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier.
Outcome measures: Primary outcome: a composite endpoint of time to recovery of upper and lower gastrointestinal function (GI-2). Secondary outcomes: time to discharge order written, length of hospital stay, postoperative pain scores and analgesic requirement, and postoperative 30-day morbidity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simon SM Ng, MD
- Phone Number: (852) 3505 1495
- Email: simonng@surgery.cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital
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Contact:
- Simon SM Ng, MD
- Phone Number: (852) 3505 1495
- Email: simonng@surgery.cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive patients (aged between 18 and 80) with mid/low rectal cancer (adenocarcinoma in the rectum of which the lowest margin of the tumor is located within 12 cm of the anal verge as measured by rigid sigmoidoscopy) undergoing laparoscopic sphincter-preserving TME or APR without the need of conversion
- American Society of Anesthesiologists grading I-III
- Informed consent available
Exclusion Criteria:
- Patients with previous experience of acupuncture
- Those undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases
- Those undergoing laparoscopic resection of rectal cancer with en bloc resection of surrounding organs
- Those who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion
- Those undergoing emergency surgery
- Those with previous history of midline laparotomy
- Those with evidence of peritoneal carcinomatosis
- Those who are expected to receive epidural anesthesia or analgesia
- Those with cardiac pacemaker
- Those who are pregnant
- Those who are allergic to the acupuncture needles
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electroacupuncture (EA)
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 needles
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Refer to arm description
Other Names:
Refer to arm description
Other Names:
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Sham Comparator: Sham Acupuncture (SA)
Sterile blunt-tip needles will be placed (without skin penetration) 20 mm away from the acupoints.
The needle will be first inserted through a sterile plastic tube mounted on a foam block, and then pressed on the skin.
The foam block compresses to give the impression that the needle is penetrating the skin, thus providing a SA effect.
'Pseudostimulation' will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.
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Refer to arm description
Other Names:
Refer to arm description
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GI-2 recovery
Time Frame: Up to 10 days
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A composite assessment that measured upper (first tolerance of solid food) and lower (first bowel movement) GI tract recovery, with time to achieve GI-2 recovery based on the last event to occur
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Up to 10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative analgesic requirement
Time Frame: Up to 1 month
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Up to 1 month
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Length of hospital stay
Time Frame: Up to 1 month
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Up to 1 month
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Time of first passing flatus
Time Frame: Up to 10 days
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Up to 10 days
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Pain scores on the first 3 postoperative days
Time Frame: Up to postoperative day 3
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On visual analog scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable)
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Up to postoperative day 3
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Short-term morbidity
Time Frame: Up to 1 month
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Defined by the Clavien-Dindo classification of surgical complications
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Up to 1 month
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Adverse events related to EA/SA
Time Frame: Up to 1 month
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Up to 1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC Ref. No.: 2017.010-T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
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Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
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