Paralytic IleusPhase 2/3NCT01389986
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
A Phase 2/3 study testing Gum chewing in people with Paralytic Ileus, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Paralytic Ileus
- 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
- 0 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2011to Sep 2013
- Phase
- Phase 2/3
- 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
- Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital
Who cannot join
- Perioperative hyperalimentation
- Recent chemotherapy (within 3 weeks before surgery)
- Previous bowel surgery
- Inflammatory bowel diseases
- Previous abdominal or pelvic radiation
- Need for immediate postoperative endotracheal intubation
- Need for postoperative admission to intensive care unit
- Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
About this study
Official title: Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial
Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complications, and patients' satisfaction.
- Conditions
- Paralytic Ileus
- Being tested
- Gum chewing
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum chewingBehavioural
Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
| Study group | Role | What they receive |
|---|---|---|
| Gum chewing | Experimental | Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule Receives: Behavioral: Gum chewing |
| Conventional | No intervention | Conventional postoperative feeding schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Measured: Up to 7 days after surgery
Secondary outcomes (7)
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort
Measured: Up to 7 days after surgery
Incidence of postoperative complications
Measured: Up to 7 days after surgery
Time to first regular diet
Measured: Up to 7 days after surgery
Time to first defecation
Measured: Up to 7 days after surgery
Postoperative analgesics requirement
Measured: Up to 7 days after surgery
Hospital stay
Measured: On the day of hospital discharge, an expected average of 7 days
Patients' satisfaction
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389986
- Sponsor's protocol ID
- GUM-ET/OV
- Status last verified
- Aug 2016
- First submitted
- 5 Jul 2011
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01389986
- Acronym / sponsor ID
- GUM-ET/OV
- Conditions
- Paralytic Ileus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Jul 2011 (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.
Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complications, and patients' satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum chewing | Experimental | Behavioral: Gum chewingGum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule |
| Conventional | No intervention | –Conventional postoperative feeding schedule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital
Key exclusion criteria (8 listed)
- Perioperative hyperalimentation
- Recent chemotherapy (within 3 weeks before surgery)
- Previous bowel surgery
- Inflammatory bowel diseases
- Previous abdominal or pelvic radiation
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 chewingGum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule | Behavioural | Gum chewing |
Primary outcome
Time to first flatus
Time frame: Up to 7 days after surgery
7 secondary outcomes
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort
Time frame: Up to 7 days after surgery
Incidence of postoperative complications
Time frame: Up to 7 days after surgery
Time to first regular diet
Time frame: Up to 7 days after surgery
Time to first defecation
Time frame: Up to 7 days after surgery
Postoperative analgesics requirement
Time frame: Up to 7 days after surgery
Hospital stay
Time frame: On the day of hospital discharge, an expected average of 7 days
Patients' satisfaction
Time frame: Up to 7 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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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.
Kittipat Charoenkwan, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gum chewing in people with Paralytic Ileus, run by Chiang Mai University at 1 site in Thailand.
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Aug 2016. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 first flatus (time frame: Up to 7 days after 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 30 Aug 2016.