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Phase 1 N=41 Randomized Double-blind Prevention

Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients

Post Operative Ileus

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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