Phase 1
N=41
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
Post Operative Ileus
Bottom Line
View on ClinicalTrials.gov: NCT01583452 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Post-Operative Hospital Stay — 79.93; 72.94 hours — p=0.665
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Chewing Gum (Other)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Operative Hospital Stay |
79.93; 72.94 | 0.665 |
| SECONDARY Time to First Flatus |
17.18; 24.37 | 0.094 |
| SECONDARY Time to First Bowel Movement |
29.91; 34.5 | 0.059 |
| SECONDARY Time to Tolerate Feedings (Oral Intake) |
31.21; 27.04 | 0.830 |
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.
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.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients who underwent any type of gastrointestinal surgery.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01583452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.