Gastrointestinal Disorder PostoperativeNCT02455739
Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
A study testing chewing gum in people with Gastrointestinal Disorder Postoperative, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to assess whether postoperative gum chewing improve intestinal functions. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorder Postoperative
- What is being tested?
- chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Jul 2015
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women underwent gynecologic operation
- Women who are eligible for gum chewing
Who cannot join
- Women with previous gastrointestinal intervantion
- Women with previous abdominal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil
Istanbul
enis ozkaya, md, enokaya1979@gmail.com
About this study
Official title: Effect of Gum Chewing on Intestinal Functions After Gynecologic Operations
The investigators aimed to assess whether postoperative gum chewing improve intestinal functions.
Read the detailed description
We will randomize patients into two groups after gynecologic operations. One group will chew gum, the other group not and we will assess the gastrointestinal function functions.
- Conditions
- Gastrointestinal Disorder Postoperative
- Being tested
- chewing gum
- Keywords
- intestinal function, chewing gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
postoperative gum chewing to improve gastrointestinal function
| Study group | Role | What they receive |
|---|---|---|
| chewing gum positive | Experimental | chewing gum group will chew gum Receives: Other: chewing gum |
| chewing gum negative | No intervention | chewing gum group will not chew gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointesitinal function
Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded
Measured: postoperative first 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Disorder PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Ateş Karateke, md, Study director, Zeynep Kamil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455739
- Sponsor's protocol ID
- ZEYNEP KAMIL
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gum Chewing on Intestinal Functions After Gynecologic Operations
- ClinicalTrials.gov ID
- NCT02455739
- Acronym / sponsor ID
- ZEYNEP KAMIL
- Conditions
- Gastrointestinal Disorder Postoperative
- Keywords
- intestinal function, chewing gum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 May 2015 (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 aimed to assess whether postoperative gum chewing improve intestinal functions.
Detailed description
We will randomize patients into two groups after gynecologic operations. One group will chew gum, the other group not and we will assess the gastrointestinal function functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chewing gum positive | Experimental | Other: chewing gumchewing gum group will chew gum |
| chewing gum negative | No intervention | –chewing gum group will not chew gum |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women underwent gynecologic operation
- Women who are eligible for gum chewing
Key exclusion criteria (2 listed)
- Women with previous gastrointestinal intervantion
- Women with previous abdominal surgery
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 gumpostoperative gum chewing to improve gastrointestinal function | Other | chewing gum positive |
Primary outcome
Gastrointesitinal function
Time frame: postoperative first 48 hours
Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Ateş Karateke, md study director
Zeynep Kamil
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 in people with Gastrointestinal Disorder Postoperative, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 28 May 2015. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact enis ozkaya, md (905054742459, enozkaya1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointesitinal function (time frame: postoperative first 48 hours). 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 28 May 2015.