Trial of Acupuncture for Reduction of Post-Colectomy Ileus

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00402961
First received: November 22, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.


Condition Intervention Phase
Postoperative Ileus
Colon Cancer
Pain, Postoperative
Postoperative Nausea and Vomiting
Other: Acupuncture
Other: Sham Acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting [ Time Frame: daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. ] [ Designated as safety issue: No ]
  • To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • GI-2, (also representing time to recovery of gastrointestinal [GI] function) [ Time Frame: patient first tolerated solid food,and time patient first passed a bowel movement ] [ Designated as safety issue: No ]
  • GI contractions measured with a multifunctional stethoscope [ Time Frame: duration of two minute before and immediately after each true or sham acupuncture treatment. ] [ Designated as safety issue: No ]
  • Daily pain score [ Time Frame: daily during hospitalization ] [ Designated as safety issue: No ]
  • Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day) [ Time Frame: daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. ] [ Designated as safety issue: No ]
  • Number of emetic episodes during hospital stay [ Time Frame: assement daily ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2006
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Acupuncture is the insertion of needles at certain body points.
Other: Acupuncture
Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.
Sham Comparator: 2
sham acupuncture
Other: Sham Acupuncture
Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,

Detailed Description:
  • To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture.
  • To explore whether acupuncture reduces the length of hospital stay more than sham acupuncture
  • To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting.
  • To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion.

Postoperative ileus contributes to prolonged hospital stay, readmission and postoperative morbidities in patients undergoing major abdominal surgery. Reduction of postoperative ileus is important in postoperative recovery. Postoperative pain may require opioids, which further reduce gastrointestinal (GI) motility. Postoperative nausea and vomiting hamper the resumption of oral intake. Together, these three common postoperative problems contribute to patient discomfort, delayed discharge and increased overall hospitalization costs, despite current multi-modal management options. Any safe and effective therapy in addition to current standard of care would be welcomed by patients, surgeons and hospitals.

Acupuncture is a complementary medicine modality shown to reduce postoperative pain, suppress nausea and vomiting, and promote GI motility. It is associated with few adverse events. Here we propose a randomized, sham controlled phase II study to evaluate acupuncture, in addition to conventional therapy, for its safety and effectiveness in improving postoperative recovery of colorectal cancer patients undergoing segmental or subtotal colectomy. The overall objective of this developmental project is to determine whether a more extended research project is warranted.

The specific aims are:

  • To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence for a reduction of postoperative ileus when compared to sham acupuncture. Hypothesis: acupuncture promotes upper and lower GI motility in patients experiencing postoperative ileus after colectomy more than sham acupuncture.
  • To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting. Hypothesis 2a: acupuncture reduces postoperative pain more than placebo in colectomy patients; 2b: acupuncture reduces postoperative nausea and vomiting more than placebo in colectomy patients.
  • To determine the feasibility of a phase III trial in terms of sample size, accrual rate, attrition rate and data completion. Hypothesis 3: a phase III study of acupuncture in the treatment of post-colectomy ileus in cancer patients is feasible.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women of any ethnicity
  • Age over 18 years (children are not included because colorectal cancer is rare in children).
  • Scheduled to undergo elective resection of biopsy proven colorectal cancer or suspected colorectal cancer

Exclusion Criteria:

Pre-operative factors:

  • History of major abdominal or pelvic surgery that have caused significant alteration in anatomy and function of the GI tract which may affect the endpoints of this study.
  • Laparoscopic procedures. They tend to result in less postoperative ileus.
  • Administration of epidural anesthetics or epidural opioids: these have previously been shown to affect postoperative GI motility. They made up only 5% of colectomy patients in the investigators' institution.
  • Acupuncture within the last 4 weeks (to exclude any possible residual effect from acupuncture)
  • Contraindications to use of electrical stimulation, including cardiac pacemaker and implantable cardioverter defibrillator (ICD)
  • Prior serious adverse event with acupuncture
  • Intra-operative events (these events alter the postoperative recovery course significantly):

    • Resection incorporating the upper GI tract. Such surgeries are usually more complex, involving more organs and are associated with a more diverse postoperative course, making the study population more heterogeneous.
    • Gross fecal spillage (high complication rate in this setting)
    • Need to leave nasogastric tube in (contaminating the primary endpoint)
    • Decision to give epidural anesthetics or epidural opioids postoperatively (shown previously to change the major endpoints)
    • Complications during surgery requiring a patient to be transferred to the Intensive Care Unit (ICU) directly from the Operating Room or Post Anesthesia Care Unit (PACU) as this also alters the postoperative course significantly. Patients transferred to the floor first will not be excluded. They will be fully registered and randomized. If they deteriorate later during the hospital stay, requiring a transfer to the ICU, they will still be followed.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00402961

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Gary Deng, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00402961     History of Changes
Obsolete Identifiers: NCT00425412
Other Study ID Numbers: 06-145
Study First Received: November 22, 2006
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Acupuncture
Post-Colectomy Ileus
Abdominal Surgery
Colon Surgery

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pain, Postoperative
Ileus
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
Pain
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014