Postoperative CareNCT01549353
Gum Chewing After Gynecologic Laparoscopy
A study testing gum chewing in people with Postoperative Care, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
Trial summary
Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Care
- What is being tested?
- gum chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Sep 2012
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all gynecologic laparoscopic surgery
- normal level of CA 125 postmenopausal
Who cannot join
- loose teeth
- chronic obstipation
- laparotomy
- operations longer then 3 h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?
Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.
- Conditions
- Postoperative Care
- Being tested
- gum chewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gum chewingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| chewing gum | Experimental | Not described Receives: Behavioral: gum chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to active bowel movements
First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured.
Measured: participants will be followed for the duration of hospital stay
Secondary outcomes (2)
patient satisfaction with postoperative gum chewing
Satisfaction will be measured with a visual analog scale (1 participant would never chew gum postoperatively again - 10 participant would always like to chew gum postoperatively)
Measured: participants will be followed for the duration of the hospital stay
Number of participants with adverse events
All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...)
Measured: participants will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionSep 2012
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 CareStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Klagenfurt am Wörthersee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549353
- Sponsor's protocol ID
- A 02/10
- Status last verified
- Dec 2012
- First submitted
- 23 Feb 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Husslein H, Franz M, Gutschi M, Worda C, Polterauer S, Leipold H. Postoperative gum chewing after gynecologic laparoscopic surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):85-90. doi: 10.1097/AOG.0b013e3182983e92.
PubMed 23743472
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?
- ClinicalTrials.gov ID
- NCT01549353
- Acronym / sponsor ID
- A 02/10
- Conditions
- Postoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Klinikum Klagenfurt am WörtherseeUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Mar 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.
Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chewing gum | Experimental | Behavioral: gum chewing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all gynecologic laparoscopic surgery
- normal level of CA 125 postmenopausal
Key exclusion criteria (4 listed)
- loose teeth
- chronic obstipation
- laparotomy
- operations longer then 3 h
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 |
|---|---|---|
| gum chewing | Behavioural | chewing gum |
Primary outcome
Time to return to active bowel movements
Time frame: participants will be followed for the duration of hospital stay
First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured.
2 secondary outcomes
patient satisfaction with postoperative gum chewing
Time frame: participants will be followed for the duration of the hospital stay
Number of participants with adverse events
Time frame: participants will be followed for the duration of hospital stay
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 4 Dec 2012.
- Derived from this study: PubMed 23743472Husslein H, Franz M, Gutschi M, Worda C, Polterauer S, Leipold H. Postoperative gum chewing after gynecologic laparoscopic surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):85-90. doi: 10.1097/AOG.0b013e3182983e92.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gum chewing in people with Postoperative Care, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
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 4 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 4 Dec 2012. 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 Austria. 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?
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 return to active bowel movements (time frame: participants will be followed for the duration of hospital stay). 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 NCT01549353, 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 4 Dec 2012.