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Clinical Trials/NCT01583452
NCT01583452
Completed
Phase 1

Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery

Instituto Tecnologico y de Estudios Superiores de Monterey1 site in 1 country41 target enrollmentApril 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Post Operative Ileus
Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Enrollment
41
Locations
1
Primary Endpoint
Post-Operative Hospital Stay
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
September 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Responsible Party
Principal Investigator
Principal Investigator

Gabriela López Jaimez

Pediatrics Resident

Instituto Tecnologico y de Estudios Superiores de Monterey

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Time to First Flatus(End of surgery to first flatus (from 1 to 3 days))
  • Time to First Bowel Movement(End of surgery to first bowel motion (from 1 to 7 days))
  • Time to Tolerate Feedings (Oral Intake)(End of surgery to oral intake tolerance (from 1 to 3 days))

Study Sites (1)

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