Postoperative IleusPhase 1/2GumGynNCT01579175
The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery
A Phase 1/2 study testing Chewing gum in people with Postoperative Ileus, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Feb 2013
- Phase
- Phase 1/2
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Undergoing benign gynecologic surgery via an exploratory laparotomy
- Capable of giving consent
Who cannot join
- Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
- Intubated or unconscious when leaving the OR
- Bowel resection performed at the time of surgery
- Active bowel disease (IBD, appendicitis, etc)
- Gynecologic malignancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.
The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.
- Conditions
- Postoperative Ileus
- Being tested
- Chewing gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
Also called Extra spearment sugar free gum
Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard postoperative care | No intervention | Not described |
| Chewing gum arm | Experimental | Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes Receives: Other: Chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to flatus
Measured: 30 days
Secondary outcomes (4)
Postoperative ileus
Nausea, vomiting, abdominal distention two episodes of 100cc of emesis
Measured: 30 days
time to discharge
Measured: 30 days
time to toleration of diet
Measured: 30 days
patient satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Sewell, Johns Hopkins University
- Investigators
- Catherine A Sewell, MD, MPH, Principal investigator, Johns Hopkins UniversityAmelia M Jernigan, MD, Study chair, Johns Hopkins UniversityGrace Chen, MD, Study director, Johns Hopkins Bayview
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579175
- Sponsor's protocol ID
- NA_00036423
- Acronym
- GumGyn
- Status last verified
- Mar 2013
- First submitted
- 13 Apr 2012
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jernigan AM, Chen CC, Sewell C. A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery. Int J Gynaecol Obstet. 2014 Dec;127(3):279-82. doi: 10.1016/j.ijgo.2014.06.008. Epub 2014 Jul 21.
PubMed 25147092
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.
- ClinicalTrials.gov ID
- NCT01579175
- Acronym / sponsor ID
- GumGyn / NA_00036423
- Conditions
- Postoperative Ileus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Apr 2012 (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 investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard postoperative care | No intervention | – |
| Chewing gum arm | Experimental | Other: Chewing gumSugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Undergoing benign gynecologic surgery via an exploratory laparotomy
- Capable of giving consent
Key exclusion criteria (5 listed)
- Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
- Intubated or unconscious when leaving the OR
- Bowel resection performed at the time of surgery
- Active bowel disease (IBD, appendicitis, etc)
- Gynecologic malignancy
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 gumAlso: Extra spearment sugar free gumSugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes. | Other | Chewing gum arm |
Primary outcome
Time to flatus
Time frame: 30 days
4 secondary outcomes
Postoperative ileus
Time frame: 30 days
time to discharge
Time frame: 30 days
time to toleration of diet
Time frame: 30 days
patient satisfaction
Time frame: 30 days
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 2013.
- Derived from this study: PubMed 25147092Jernigan AM, Chen CC, Sewell C. A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery. Int J Gynaecol Obstet. 2014 Dec;127(3):279-82. doi: 10.1016/j.ijgo.2014.06.008. Epub 2014 Jul 21.
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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.
Catherine A Sewell, MD, MPH principal investigator
Johns Hopkins University
Amelia M Jernigan, MD study chair
Johns Hopkins University
Grace Chen, MD study director
Johns Hopkins Bayview
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chewing gum in people with Postoperative Ileus, run by Johns Hopkins University 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 5 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 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Time to flatus (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01579175, which also lists 1 linked publication.
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 2013.