Colorectal CancerNCT02372500
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
A study testing Chewing gum in people with Colorectal Cancer and Surgery, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- Chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Oct 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
Who cannot join
- Emergency colorectal surgery, unable to consent
Trial locations and contacts
1 site in 1 country.
Sheila Williams contact
United Kingdom1 site
Countess of Chester Hospital
Chester, Cheshire, CH2 1UL
About this study
Official title: Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.
Read the detailed description
Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.
The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).
The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)
- Conditions
- Colorectal Cancer, Surgery
- Being tested
- Chewing gum
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumDietary supplement
Sugar free chewing gum
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Patients will chew sugar free gum three times a day Receives: Dietary Supplement: Chewing gum |
| Control | No intervention | Normal post operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel function (as assessed by questionnaire)
Time to passage of flatus
Measured: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Secondary outcomes (4)
Diet (as assessed by questionnaire)
Time to tolerating full diet
Measured: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)
Length of stay
Measured: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)
Post op nausea and vomiting score (as recorded by visual analogue scale)
Post op nausea and vomiting score (PONV)
Measured: Recorded daily for first 5 days
Morbidity
Post operative morbidity
Measured: Days (recorded up to 30 days and defined by Clavien-Dindo scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dale Vimalachandran, Countess of Chester NHS Foundation Trust
- Investigators
- Dale Vimalachandran, MD FRCS, Study director, Countess of ChesterRachel Clifford, MRCS, Principal investigator, Countess of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372500
- Sponsor's protocol ID
- Surg050/14
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02372500
- Acronym / sponsor ID
- Surg050/14
- Conditions
- Colorectal Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 26 Feb 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.
It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.
Detailed description
Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.
The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).
The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Dietary Supplement: Chewing gumPatients will chew sugar free gum three times a day |
| Control | No intervention | –Normal post operative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
Key exclusion criteria (1 listed)
- Emergency colorectal surgery, unable to consent
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 gumSugar free chewing gum | Dietary supplement | Chewing gum |
Primary outcome
Bowel function (as assessed by questionnaire)
Time frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Time to passage of flatus
4 secondary outcomes
Diet (as assessed by questionnaire)
Time frame: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)
Length of stay
Time frame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)
Post op nausea and vomiting score (as recorded by visual analogue scale)
Time frame: Recorded daily for first 5 days
Morbidity
Time frame: Days (recorded up to 30 days and defined by Clavien-Dindo scale)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.
Sheila Williams contact
Dale Vimalachandran, MD FRCS study director
Countess of Chester
Rachel Clifford, MRCS principal investigator
Countess of Chester
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 Colorectal Cancer and Surgery, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 26 Feb 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 United Kingdom. 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 Dale Vimalachandran, MD FRCS (4401244365475, dale.vimalachandran@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function (as assessed by questionnaire) (time frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)). 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 26 Feb 2015.