Back to resultsAcupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
Primary Purpose
Ileus, Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Ileus focused on measuring Colostomy, Ileostomy
Eligibility Criteria
Inclusion Criteria: Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure Hospital admission must be same day as surgery Exclusion Criteria: Incapacitating disease Concurrent herbal or laxative use Use of Heparin or Coumadin Upper or lower extremity deformities Chronic constipation prior to cancer diagnosis History of cerebrovascular accident or spinal cord injury Chronic pain that has been treated with any form of major opioid or weak opioids (=/> 30mg/24 hours) Pacemaker or metal implants Concurrent alternative medicine/herbal use
Sites / Locations
- MD Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00065234
First Posted
July 18, 2003
Last Updated
March 27, 2017
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00065234
Brief Title
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
Official Title
Acupuncture to Prevent Postoperative Paralytic Ileus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Neoplasms
Keywords
Colostomy, Ileostomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
Hospital admission must be same day as surgery
Exclusion Criteria:
Incapacitating disease
Concurrent herbal or laxative use
Use of Heparin or Coumadin
Upper or lower extremity deformities
Chronic constipation prior to cancer diagnosis
History of cerebrovascular accident or spinal cord injury
Chronic pain that has been treated with any form of major opioid or weak opioids (=/> 30mg/24 hours)
Pacemaker or metal implants
Concurrent alternative medicine/herbal use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph S Chiang, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
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