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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier:
NCT01583452
First received: April 3, 2012
Last updated: September 8, 2012
Last verified: September 2012

April 3, 2012
September 8, 2012
April 2012
August 2012   (final data collection date for primary outcome measure)
Reduce the post-operative hospital stay [ Time Frame: End of surgery to hospital discharge (from 4 to 7 days) ] [ Designated as safety issue: No ]
The time between the end of surgery and hospital discharge, measured in hours
Same as current
Complete list of historical versions of study NCT01583452 on ClinicalTrials.gov Archive Site
  • Reduce time to first flatus [ Time Frame: End of surgery to first flatus (from 1 to 3 days) ] [ Designated as safety issue: No ]
    The time between the end of surgery and the moment in which the patient passes first flatus
  • Reduce the time to first bowel motion [ Time Frame: End of surgery to first bowel motion (from 1 to 7 days) ] [ Designated as safety issue: No ]
    The time between the end of surgery and the moment in which the patient presents first bowel motion
  • Reduce time to oral intake tolerance [ Time Frame: End of surgery to oral intake tolerance (from 1 to 3 days) ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Post Operative Ileus
Other: Chewing Gum
The use of chewing gum as a preventive measure for post-operative ileus
Other Names:
  • Sugarless chewing gum
  • Trident
  • Orbit
  • Ice Breakers
  • Smint
  • Experimental: Chewing Gum Group
    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.
    Intervention: 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01583452
UGoMaRIPO
Yes
Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
Instituto Tecnologico y de Estudios Superiores de Monterey
Not Provided
Principal Investigator: Gabriela Lopez, MD Instituto Tecnologico y de Estudios Superiores de Monterey
Instituto Tecnologico y de Estudios Superiores de Monterey
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP