IleusPhase 2NCT00065234
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
A Phase 2 study testing Acupuncture in people with Ileus and Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
- Hospital admission must be same day as surgery
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture to Prevent Postoperative Paralytic Ileus
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.
- Being tested
- Acupuncture
- Keywords
- Colostomy, Ileostomy
- Medical subject headings
- Ileus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2003 (estimated)
- Study startSep 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joseph S Chiang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065234
- Sponsor's protocol ID
- R21AT001065-01A1
- Other IDs
- ChiangJ
- Status last verified
- Mar 2017
- First submitted
- 18 Jul 2003
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture to Prevent Postoperative Paralytic Ileus
- ClinicalTrials.gov ID
- NCT00065234
- Acronym / sponsor ID
- R21AT001065-01A1
- Keywords
- Colostomy, Ileostomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- May 2006
- First posted
- 22 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
- Hospital admission must be same day as surgery
Key exclusion criteria (9 listed)
- Incapacitating disease
- Concurrent herbal or laxative use
- Use of Heparin or Coumadin
- Upper or lower extremity deformities
- Chronic constipation prior to cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph S Chiang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with Ileus and Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.