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Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Primary Purpose

Postoperative Ileus, Colon Cancer, Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring Acupuncture, Post-Colectomy Ileus, Abdominal Surgery, Colon Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center 1275 York Avenue

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

2

Arm Description

Acupuncture is the insertion of needles at certain body points.

sham acupuncture

Outcomes

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

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
To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion
GI-2, (also representing time to recovery of gastrointestinal [GI] function)
GI contractions measured with a multifunctional stethoscope
Daily pain score
Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day)
Number of emetic episodes during hospital stay

Full Information

First Posted
November 22, 2006
Last Updated
October 9, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00402961
Brief Title
Trial of Acupuncture for Reduction of Post-Colectomy Ileus
Official Title
A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus, Colon Cancer, Pain, Postoperative, Postoperative Nausea and Vomiting
Keywords
Acupuncture, Post-Colectomy Ileus, Abdominal Surgery, Colon Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Acupuncture is the insertion of needles at certain body points.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
sham acupuncture
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
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,
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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
Title
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
Title
GI contractions measured with a multifunctional stethoscope
Time Frame
duration of two minute before and immediately after each true or sham acupuncture treatment.
Title
Daily pain score
Time Frame
daily during hospitalization
Title
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.
Title
Number of emetic episodes during hospital stay
Time Frame
assement daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Deng, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

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Trial of Acupuncture for Reduction of Post-Colectomy Ileus

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