Colorectal CancerNCT02419586
Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
A study testing bubble gum in people with Colorectal Cancer, run by Shum Nga Fan at 1 site in China.
Trial summary
Gum chewing group will have less ileus and early resume of bowel motion than control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bubble gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 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
- Patients with newly diagnosed colorectal cancer undergoing laparoscopic resection in in Queen Mary Hospital
- At least 18 years
- Speak Cantonese
- Able to follow study protocol and chewing gum study
Who cannot join
- Cognitive disability
- Requirement of epidural analgesia
- Requirement of intensive care unit/ High dependency unit care postoperatively
- Inability to chew
- Presence of procedure other than colorectal resection
- Non Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Gum Chewing on Reduction of Postoperative Paralytic Ileus for Chinese Colorectal Cancer Patients Underwent Laparoscopic Colorectal Surgery and Enhanced Recovery Program
Gum chewing group will have less ileus and early resume of bowel motion than control group.
Read the detailed description
The standardize surgical techniques, less used of epidural analgesia, early ambulation and used of naso-gastric tube for decompression are aimed to reduce the paralytic ileus after abdominal surgery . Most Western studies have examined and found that gum chewing are able to prevent postoperative ileus or promotes early bowel function after abdominal surgery.
- Conditions
- Colorectal Cancer
- Being tested
- bubble 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.
bubble gumOther
Chewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged.
| Study group | Role | What they receive |
|---|---|---|
| bubble gum chewing and routine care | Experimental | Start chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged Receives: Other: bubble gum |
| routine care | No intervention | Non interventional group will receive existing routine care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Time to passage of flatus after surgery was significantly shorter in the intervention group (22 vs 39 hours, p=0.007).
Measured: from postoperative day 0 till an expected average of day 7
Secondary outcomes (3)
Time to first sense of hunger
Patients in the intervention group also noticed feeling of hunger earlier (17 vs 40 hours, p<0.001).
Measured: from postoperative day 0 till an expected average of day 7
Time to first bowel movement,
The first bowel motion also occurred earlier in the intervention group (22 vs 52 hours, p<0.001)
Measured: from postoperative day 0 till an expected average of day 7
Length of stay
There is no difference in length of stay between intervention group or control group
Measured: from postoperative day 0 till an expected average of day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJun 2016
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 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shum Nga Fan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Shum Nga Fan, Hospital Authority, Hong Kong
- Investigators
- Nga Fan Shum, Principal investigator, Hospital Authority, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419586
- Sponsor's protocol ID
- CRC03
- Status last verified
- Jun 2018
- First submitted
- 4 Mar 2015
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shum NF, Choi HK, Mak JC, Foo DC, Li WC, Law WL. Randomized clinical trial of chewing gum after laparoscopic colorectal resection. Br J Surg. 2016 Oct;103(11):1447-52. doi: 10.1002/bjs.10277.
PubMed 27654648
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gum Chewing on Reduction of Postoperative Paralytic Ileus for Chinese Colorectal Cancer Patients Underwent Laparoscopic Colorectal Surgery and Enhanced Recovery Program
- ClinicalTrials.gov ID
- NCT02419586
- Acronym / sponsor ID
- CRC03
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shum Nga FanOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Apr 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.
Gum chewing group will have less ileus and early resume of bowel motion than control group.
Detailed description
The standardize surgical techniques, less used of epidural analgesia, early ambulation and used of naso-gastric tube for decompression are aimed to reduce the paralytic ileus after abdominal surgery . Most Western studies have examined and found that gum chewing are able to prevent postoperative ileus or promotes early bowel function after abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bubble gum chewing and routine care | Experimental | Other: bubble gumStart chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged |
| routine care | No intervention | –Non interventional group will receive existing routine care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed colorectal cancer undergoing laparoscopic resection in in Queen Mary Hospital
- At least 18 years
- Speak Cantonese
- Able to follow study protocol and chewing gum study
Key exclusion criteria (6 listed)
- Cognitive disability
- Requirement of epidural analgesia
- Requirement of intensive care unit/ High dependency unit care postoperatively
- Inability to chew
- Presence of procedure other than colorectal resection
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 |
|---|---|---|
| bubble gumChewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged. | Other | bubble gum chewing and routine care |
Primary outcome
Time to first flatus
Time frame: from postoperative day 0 till an expected average of day 7
Time to passage of flatus after surgery was significantly shorter in the intervention group (22 vs 39 hours, p=0.007).
3 secondary outcomes
Time to first sense of hunger
Time frame: from postoperative day 0 till an expected average of day 7
Time to first bowel movement,
Time frame: from postoperative day 0 till an expected average of day 7
Length of stay
Time frame: from postoperative day 0 till an expected average of day 7
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 21 Jun 2018.
- Derived from this study: PubMed 27654648Shum NF, Choi HK, Mak JC, Foo DC, Li WC, Law WL. Randomized clinical trial of chewing gum after laparoscopic colorectal resection. Br J Surg. 2016 Oct;103(11):1447-52. doi: 10.1002/bjs.10277.
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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.
Nga Fan Shum principal investigator
Hospital Authority, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bubble gum in people with Colorectal Cancer, run by Shum Nga Fan at 1 site in China.
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 4 inclusion and 6 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 21 Jun 2018. 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 China. 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 first flatus (time frame: from postoperative day 0 till an expected average of day 7). 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 NCT02419586, 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 21 Jun 2018.