IleusNCT00831246
Prevention of Ileus After Gynecologic Surgery Using Chewing Gum
A study testing chewing gum - Extra Winterfresh and Standard Post-Op Care in people with Ileus, run by Aultman Health Foundation at 1 site in United States.
Trial summary
This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ileus
- What is being tested?
- chewing gum - Extra Winterfresh and Standard Post-Op Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.
- Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation.
Who cannot join
- Patient deemed legally incompetent to sign their own consent
- Women under the age of 18
- Patients lacking their own or a false set of teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum
This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.
- Conditions
- Ileus
- Being tested
- chewing gum - Extra Winterfresh, Standard Post-Op Care
- Keywords
- Ileus,, Gynecologic surgery,, Post-operative,, Flatus
- Medical subject headings
- Ileus, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gum - Extra WinterfreshOther
Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
Standard Post-Op CareOther
Patients are given standard post-op care with clear liquid diet as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals. Receives: Other: chewing gum - Extra Winterfresh |
| 2 | Sham comparator | Patients are given standard post-op care with clear liquid diet as tolerated . Receives: Other: Standard Post-Op Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ileus
Measured: Until ileus formation or first flatus post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aultman Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Hopkins, MD, Study chair, Aultman Health FoundationJames M Clark, MD, Principal investigator, Aultman Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831246
- Sponsor's protocol ID
- 2008.03.27.E2
- Other IDs
- 2008 JMC
- Status last verified
- Aug 2018
- First submitted
- 27 Jan 2009
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum
- ClinicalTrials.gov ID
- NCT00831246
- Acronym / sponsor ID
- 2008.03.27.E2
- Conditions
- Ileus
- Keywords
- Ileus,, Gynecologic surgery,, Post-operative,, Flatus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aultman Health FoundationUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Jan 2009 (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.
This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: chewing gum - Extra WinterfreshPatients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals. |
| 2 | Sham comparator | Other: Standard Post-Op CarePatients are given standard post-op care with clear liquid diet as tolerated . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.
- Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation.
Key exclusion criteria (3 listed)
- Patient deemed legally incompetent to sign their own consent
- Women under the age of 18
- Patients lacking their own or a false set of teeth
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 |
|---|---|---|
| chewing gum - Extra WinterfreshPatients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals. | Other | 1 |
| Standard Post-Op CarePatients are given standard post-op care with clear liquid diet as tolerated. | Other | 2 |
Primary outcome
Incidence of ileus
Time frame: Until ileus formation or first flatus post-op
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 21 Aug 2018.
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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.
Michael Hopkins, MD study chair
Aultman Health Foundation
James M Clark, MD principal investigator
Aultman Health Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum - Extra Winterfresh and Standard Post-Op Care in people with Ileus, run by Aultman Health Foundation 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 3 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 21 Aug 2018. 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. 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?
Incidence of ileus (time frame: Until ileus formation or first flatus post-op). 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 21 Aug 2018.