Postoperative IleusNCT01559662
Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
A study testing Sugared Chewing Gum (Juicy Fruit) in people with Postoperative Ileus, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Sugared Chewing Gum (Juicy Fruit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
Who cannot join
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- American Society of Anesthesiologists (ASA) Class IV or V;
- History of abdominal carcinomatosis
- History of radiation enteritis
- Children < 18 or adults > 85 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.
- Conditions
- Postoperative Ileus
- Being tested
- Sugared Chewing Gum (Juicy Fruit)
- Keywords
- chewing gum, ileus, gastrointestinal function, colorectal surgery, abdominal surgery
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugared Chewing Gum (Juicy Fruit)Dietary supplement
One stick of gum, 3 times daily from Postoperative day 1 to 7
| Study group | Role | What they receive |
|---|---|---|
| Sugared Chewing Gum | Experimental | Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time Receives: Dietary Supplement: Sugared Chewing Gum (Juicy Fruit) |
| No Gum | No intervention | No gum given, routine postoperative care provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in hours) to tolerating a low residue diet
Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours
Measured: 30 day postoperative period
Secondary outcomes (7)
Time (in hours) to passage of flatus
Time from end of operation to first passage of flatus (reported by patient)
Measured: 30 day postoperative period
Time (hours) to first bowel movement
Time (hours) from end of operation to first bowel movement
Measured: 30 day postoperative period
Daily Appetite Assessment
Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)
Measured: Postoperative day 1 - 7
Daily pain assessment
Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)
Measured: Postoperative day 1 - 7
Daily nausea assessment
Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)
Measured: Postoperative day 1 - 7
Major or Minor Medical and Surgical Complications
Measured: 30 day postoperative period
Length of postoperative hospitalization in days
Measured: Duration of postoperative hospitalization (expected average of 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Fleshner MD, Cedars-Sinai Medical Center
- Investigators
- Phillip Fleshner, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559662
- Sponsor's protocol ID
- CSMCGumStudy
- Status last verified
- Aug 2012
- First submitted
- 16 Mar 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding
- ClinicalTrials.gov ID
- NCT01559662
- Acronym / sponsor ID
- CSMCGumStudy
- Conditions
- Postoperative Ileus
- Keywords
- chewing gum, ileus, gastrointestinal function, colorectal surgery, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 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.
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugared Chewing Gum | Experimental | Dietary Supplement: Sugared Chewing Gum (Juicy Fruit)Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time |
| No Gum | No intervention | –No gum given, routine postoperative care provided |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
Key exclusion criteria (5 listed)
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- American Society of Anesthesiologists (ASA) Class IV or V;
- History of abdominal carcinomatosis
- History of radiation enteritis
- Children < 18 or adults > 85 years of age
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 |
|---|---|---|
| Sugared Chewing Gum (Juicy Fruit)One stick of gum, 3 times daily from Postoperative day 1 to 7 | Dietary supplement | Sugared Chewing Gum |
Primary outcome
Time (in hours) to tolerating a low residue diet
Time frame: 30 day postoperative period
Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours
7 secondary outcomes
Time (in hours) to passage of flatus
Time frame: 30 day postoperative period
Time (hours) to first bowel movement
Time frame: 30 day postoperative period
Daily Appetite Assessment
Time frame: Postoperative day 1 - 7
Daily pain assessment
Time frame: Postoperative day 1 - 7
Daily nausea assessment
Time frame: Postoperative day 1 - 7
Major or Minor Medical and Surgical Complications
Time frame: 30 day postoperative period
Length of postoperative hospitalization in days
Time frame: Duration of postoperative hospitalization (expected average of 5 days)
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 15 Aug 2012.
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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.
Phillip Fleshner, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugared Chewing Gum (Juicy Fruit) in people with Postoperative Ileus, run by Cedars-Sinai Medical Center at 1 site in United States.
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 3 inclusion and 5 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 15 Aug 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 United States. 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 (in hours) to tolerating a low residue diet (time frame: 30 day postoperative period). 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 15 Aug 2012.