IleusNCT00655317
Acupuncture and Post-Operative Ileus
A study testing Acupuncture in people with Ileus, run by Mayo Clinic at 2 sites in United States.
Trial summary
Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ileus
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jan 2011
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- age 18-89
- colorectal pathology requiring standard elective open or laparoscopic colectomy
Who cannot join
- pregnancy
- pacemaker or implantable electronic devices
- bowel obstruction
- intra-abdominal abscess or sepsis
- colorectal tumors invading other organs or surrounding tissues
- diverticulitis complicated by fistula
Show all 13Show fewer
- known immunodeficiency disorders
- tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery
- chronic pain medications
- surgeries requiring temporary or permanent ostomies
- emergent operations
- receiving preoperative radiation/chemotherapy
- major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Acupuncture and Post-Operative Ileus: A Prospective Randomized Study to Evaluate the Effects of Electrostimulated Acupuncture on Recovery From Ileus Following Standard Elective Colon Surgery
Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. However, this has not been studied in a randomized, prospective fashion in colon surgery. The goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.
Read the detailed description
The pathogenesis of post-operative ileus is not completely known. It is thought that post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. These in turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. Acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery.
The study goals are to determine if acupuncture:
- Leads to earlier return of bowel function
- Leads to earlier time to discharge following colon surgery
- Leads to earlier return of colonic motility
- Leads to decreased postoperative nausea and vomiting
- Leads to a decrease in inflammation
- Conditions
- Ileus
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- acupuncture, colon surgery, post operative ileus, post ileus, ileus, colectomy, colorectal pathology
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
Sham acupunctureOther
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles Receives: Other: Acupuncture |
| 2 | Sham comparator | SHAM (control) acupuncture group: non-therapeutic acupuncture treatment Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.
Measured: Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery
Secondary outcomes (3)
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon
Measured: radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively
Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication
Measured: number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively
Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus
Measured: serum inflammatory markers will be measured preoperatively and postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionJan 2011
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Philip P. Metzger, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655317
- Sponsor's protocol ID
- 06-009410
- Status last verified
- Mar 2011
- First submitted
- 3 Apr 2008
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Post-Operative Ileus: A Prospective Randomized Study to Evaluate the Effects of Electrostimulated Acupuncture on Recovery From Ileus Following Standard Elective Colon Surgery
- ClinicalTrials.gov ID
- NCT00655317
- Acronym / sponsor ID
- 06-009410
- Conditions
- Ileus
- Keywords
- acupuncture, colon surgery, post operative ileus, post ileus, ileus, colectomy, colorectal pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Apr 2008 (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.
Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. However, this has not been studied in a randomized, prospective fashion in colon surgery. The goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.
Detailed description
The pathogenesis of post-operative ileus is not completely known. It is thought that post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. These in turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. Acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery.
The study goals are to determine if acupuncture:
- Leads to earlier return of bowel function
- Leads to earlier time to discharge following colon surgery
- Leads to earlier return of colonic motility
- Leads to decreased postoperative nausea and vomiting
- Leads to a decrease in inflammation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: AcupunctureTreatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles |
| 2 | Sham comparator | Other: Sham acupunctureSHAM (control) acupuncture group: non-therapeutic acupuncture treatment |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female
- age 18-89
- colorectal pathology requiring standard elective open or laparoscopic colectomy
Key exclusion criteria (13 listed)
- pregnancy
- pacemaker or implantable electronic devices
- bowel obstruction
- intra-abdominal abscess or sepsis
- colorectal tumors invading other organs or surrounding tissues
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 |
|---|---|---|
| AcupunctureTreatment acupuncture group: therapeutic acupuncture treatment with actual needles | Other | 1 |
| Sham acupunctureSHAM (control) acupuncture group: non-therapeutic acupuncture treatment | Other | 2 |
Primary outcome
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.
Time frame: Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery
3 secondary outcomes
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon
Time frame: radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively
Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication
Time frame: number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively
Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus
Time frame: serum inflammatory markers will be measured preoperatively and postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
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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.
Philip P. Metzger, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Ileus, run by Mayo Clinic at 2 sites 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery. (time frame: Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery). It is what the study was designed to measure, not a finding.
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 14 Mar 2011.