Post Operative IleusPhase 1NCT01583452
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
A Phase 1 study testing Chewing Gum in people with Post Operative Ileus, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
Trial summary
Post- operative ileus refers to the time after surgery before coordinated electromotor bowel function resumes. It's treatment and prevention may signify an elevated hospitalization cost and the exposure to the patient to adverse effects of drugs. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Post Operative Ileus
- What is being tested?
- Chewing Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients who underwent any type of gastrointestinal surgery.
Who cannot join
- Patients unable to chew
- Patients unable to swallow
- Patients whose clinical status is critical
- Patients with gastrointestinal motility disorders not associated with GI surgeries.
- Patients unable to follow directions about the use of chewing gum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery
Post- operative ileus refers to the time after surgery before coordinated electromotor bowel function resumes. It's treatment and prevention may signify an elevated hospitalization cost and the exposure to the patient to adverse effects of drugs.
The current clinical trial has as primary objective to prove the efficacy of chewing gum as a preventive measure of post-operative ileus in pediatric patients after gastrointestinal surgery through the determination of the time the patient takes to tolerate oral intake, pass flatus, present bowel movements and the time of hospital stay.
Patients will be assigned either to the case group (chewing gum + standard treatment) or to the control group (standard treatment), in both of them time from the end of surgery to the moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any type of food) and is discharged from hospital; will be measured in hours and then analyzed to determine the validity of these data.
Read the detailed description
Postoperative ileus is a relatively common condition seen in patients with gastrointestinal diseases requiring surgery. Treatment and prevention of this condition involves the use of several drugs and devices which increase the length of hospital stay, costs of treatment and morbidity.
In the last years there have been several reports about the use of chewing gum as a preventive measure of postoperative ileus with positive results in the adult population. Most of these studies involve patients who underwent colectomy. In the bibliographic review the investigators found just one study developed specifically with pediatric patients. Results are very similar between the studies; time to present first bowel movement, pass flatus and tolerate oral intake is decreased with statistically significant evidence, meanwhile, the length of hospital stay has been proved to be shortened in just a few studies.
The primary objective in the investigators study is to demonstrate chewing gum can be a cheap and easy therapeutic strategy to reduce the length of hospital stay, by diminishing the incidence and time of postoperative ileus (by the determination of the time patients take to tolerate oral intake, pass flatus and present bowel movements).
The investigators study hypothesis is stated as follows: Use of chewing gum in pediatric patients after gastrointestinal surgery reduces the risk of post-operative ileus by decreasing the time the patient takes to tolerate oral intake, pass flatus and present bowel movements.
Study Design
- Randomized Clinical Trial
- Prospective
- Experimental
Patients will be assigned either to the case group (chewing gum + standard treatment) or to the control group (standard treatment), in both of them time from the end of surgery to the moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any type of food) and is discharged from hospital; will be measured in hours and then analyzed to determine the validity of these data.
Investigators will register any adverse effect related with the use of chewing gum such as: abdominal distension, abdominal pain, nausea, vomiting, ingestion of chewing gum, intestinal obstruction, or any other patient's complain while being in hospital. Medications used during treatment will also be reported with every patient included in the protocol.
There will be no intervention of any pharmaceutic industry or support of any chewing gum brand. Costs of the study will be covered by the principal investigator.
- Conditions
- Post Operative Ileus
- Being tested
- Chewing Gum
- Keywords
- Post operative ileus, Gastrointestinal surgery, Chewing gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumOther
Also called Sugarless chewing gum, Trident, Orbit, Ice Breakers
The use of chewing gum as a preventive measure for post-operative ileus
| Study group | Role | What they receive |
|---|---|---|
| Chewing Gum Group | Experimental | Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care. Receives: Other: Chewing Gum |
| No intervention | No intervention | By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Hospital Stay
The time between the end of surgery and hospital discharge, measured in hours
Measured: End of surgery to hospital discharge (from 4 to 7 days)
Secondary outcomes (3)
Time to First Flatus
The time between the end of surgery and the moment in which the patient passes first flatus
Measured: End of surgery to first flatus (from 1 to 3 days)
Time to First Bowel Movement
The time between the end of surgery and the moment in which the patient presents first bowel movement.
Measured: End of surgery to first bowel motion (from 1 to 7 days)
Time to Tolerate Feedings (Oral Intake)
The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.
Measured: End of surgery to oral intake tolerance (from 1 to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Gabriela Lopez, MD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de Monterey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583452
- Sponsor's protocol ID
- UGoMaRIPO
- Status last verified
- Jun 2015
- First submitted
- 3 Apr 2012
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vasquez W, Hernandez AV, Garcia-Sabrido JL. Is gum chewing useful for ileus after elective colorectal surgery? A systematic review and meta-analysis of randomized clinical trials. J Gastrointest Surg. 2009 Apr;13(4):649-56. doi: 10.1007/s11605-008-0756-8. Epub 2008 Dec 3.
PubMed 19050983Johnson MD, Walsh RM. Current therapies to shorten postoperative ileus. Cleve Clin J Med. 2009 Nov;76(11):641-8. doi: 10.3949/ccjm.76a.09051.
PubMed 19884293Purkayastha S, Tilney HS, Darzi AW, Tekkis PP. Meta-analysis of randomized studies evaluating chewing gum to enhance postoperative recovery following colectomy. Arch Surg. 2008 Aug;143(8):788-93. doi: 10.1001/archsurg.143.8.788.
PubMed 18711040de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21.
PubMed 18292660Noble EJ, Harris R, Hosie KB, Thomas S, Lewis SJ. Gum chewing reduces postoperative ileus? A systematic review and meta-analysis. Int J Surg. 2009 Apr;7(2):100-5. doi: 10.1016/j.ijsu.2009.01.006. Epub 2009 Jan 31.
PubMed 19261555Fitzgerald JE, Ahmed I. Systematic review and meta-analysis of chewing-gum therapy in the reduction of postoperative paralytic ileus following gastrointestinal surgery. World J Surg. 2009 Dec;33(12):2557-66. doi: 10.1007/s00268-009-0104-5.
PubMed 19763686
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT01583452
- Acronym / sponsor ID
- UGoMaRIPO
- Conditions
- Post Operative Ileus
- Keywords
- Post operative ileus, Gastrointestinal surgery, Chewing gum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post- operative ileus refers to the time after surgery before coordinated electromotor bowel function resumes. It's treatment and prevention may signify an elevated hospitalization cost and the exposure to the patient to adverse effects of drugs.
The current clinical trial has as primary objective to prove the efficacy of chewing gum as a preventive measure of post-operative ileus in pediatric patients after gastrointestinal surgery through the determination of the time the patient takes to tolerate oral intake, pass flatus, present bowel movements and the time of hospital stay.
Patients will be assigned either to the case group (chewing gum + standard treatment) or to the control group (standard treatment), in both of them time from the end of surgery to the moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any type of food) and is discharged from hospital; will be measured in hours and then analyzed to determine the validity of these data.
Detailed description
Postoperative ileus is a relatively common condition seen in patients with gastrointestinal diseases requiring surgery. Treatment and prevention of this condition involves the use of several drugs and devices which increase the length of hospital stay, costs of treatment and morbidity.
In the last years there have been several reports about the use of chewing gum as a preventive measure of postoperative ileus with positive results in the adult population. Most of these studies involve patients who underwent colectomy. In the bibliographic review the investigators found just one study developed specifically with pediatric patients. Results are very similar between the studies; time to present first bowel movement, pass flatus and tolerate oral intake is decreased with statistically significant evidence, meanwhile, the length of hospital stay has been proved to be shortened in just a few studies.
The primary objective in the investigators study is to demonstrate chewing gum can be a cheap and easy therapeutic strategy to reduce the length of hospital stay, by diminishing the incidence and time of postoperative ileus (by the determination of the time patients take to tolerate oral intake, pass flatus and present bowel movements).
The investigators study hypothesis is stated as follows: Use of chewing gum in pediatric patients after gastrointestinal surgery reduces the risk of post-operative ileus by decreasing the time the patient takes to tolerate oral intake, pass flatus and present bowel movements.
Study Design
- Randomized Clinical Trial
- Prospective
- Experimental
Patients will be assigned either to the case group (chewing gum + standard treatment) or to the control group (standard treatment), in both of them time from the end of surgery to the moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any type of food) and is discharged from hospital; will be measured in hours and then analyzed to determine the validity of these data.
Investigators will register any adverse effect related with the use of chewing gum such as: abdominal distension, abdominal pain, nausea, vomiting, ingestion of chewing gum, intestinal obstruction, or any other patient's complain while being in hospital. Medications used during treatment will also be reported with every patient included in the protocol.
There will be no intervention of any pharmaceutic industry or support of any chewing gum brand. Costs of the study will be covered by the principal investigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing Gum Group | Experimental | Other: Chewing GumGroup of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care. |
| No intervention | No intervention | –By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients who underwent any type of gastrointestinal surgery.
Key exclusion criteria (5 listed)
- Patients unable to chew
- Patients unable to swallow
- Patients whose clinical status is critical
- Patients with gastrointestinal motility disorders not associated with GI surgeries.
- Patients unable to follow directions about the use of chewing gum
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 GumAlso: Sugarless chewing gum, Trident, Orbit, Ice BreakersThe use of chewing gum as a preventive measure for post-operative ileus | Other | Chewing Gum Group |
Primary outcome
Post-Operative Hospital Stay
Time frame: End of surgery to hospital discharge (from 4 to 7 days)
The time between the end of surgery and hospital discharge, measured in hours
3 secondary outcomes
Time to First Flatus
Time frame: End of surgery to first flatus (from 1 to 3 days)
Time to First Bowel Movement
Time frame: End of surgery to first bowel motion (from 1 to 7 days)
Time to Tolerate Feedings (Oral Intake)
Time frame: End of surgery to oral intake tolerance (from 1 to 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19050983Vasquez W, Hernandez AV, Garcia-Sabrido JL. Is gum chewing useful for ileus after elective colorectal surgery? A systematic review and meta-analysis of randomized clinical trials. J Gastrointest Surg. 2009 Apr;13(4):649-56. doi: 10.1007/s11605-008-0756-8. Epub 2008 Dec 3.
- Background: PubMed 19884293Johnson MD, Walsh RM. Current therapies to shorten postoperative ileus. Cleve Clin J Med. 2009 Nov;76(11):641-8. doi: 10.3949/ccjm.76a.09051.
- Background: PubMed 18711040Purkayastha S, Tilney HS, Darzi AW, Tekkis PP. Meta-analysis of randomized studies evaluating chewing gum to enhance postoperative recovery following colectomy. Arch Surg. 2008 Aug;143(8):788-93. doi: 10.1001/archsurg.143.8.788.
- Background: PubMed 18292660de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21.
- Background: PubMed 19261555Noble EJ, Harris R, Hosie KB, Thomas S, Lewis SJ. Gum chewing reduces postoperative ileus? A systematic review and meta-analysis. Int J Surg. 2009 Apr;7(2):100-5. doi: 10.1016/j.ijsu.2009.01.006. Epub 2009 Jan 31.
- Background: PubMed 19763686Fitzgerald JE, Ahmed I. Systematic review and meta-analysis of chewing-gum therapy in the reduction of postoperative paralytic ileus following gastrointestinal surgery. World J Surg. 2009 Dec;33(12):2557-66. doi: 10.1007/s00268-009-0104-5.
Related trials for Post Operative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
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.
Gabriela Lopez, MD principal investigator
Instituto Tecnologico y de Estudios Superiores de Monterey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chewing Gum in people with Post Operative Ileus, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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 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 23 Jul 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 Mexico. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Operative Hospital Stay (time frame: End of surgery to hospital discharge (from 4 to 7 days)). 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 NCT01583452, which also lists 6 linked publications.
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 23 Jul 2015.