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
  Purpose

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.


Condition Intervention Phase
Post Operative Ileus
Other: Chewing Gum
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery

Resource links provided by NLM:


Further study details as provided by Instituto Tecnologico y de Estudios Superiores de Monterey:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583452

Locations
Mexico
Hospital San Jose Tec de Monterrey
Monterrey, Nuevo León, Mexico, 64710
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Investigators
Principal Investigator: Gabriela Lopez, MD Instituto Tecnologico y de Estudios Superiores de Monterey
  More Information

Publications:
Responsible Party: Gabriela López Jaimez, Pediatrics Resident, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT01583452     History of Changes
Other Study ID Numbers: UGoMaRIPO
Study First Received: April 3, 2012
Last Updated: September 8, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Tecnologico y de Estudios Superiores de Monterey:
Post operative ileus
Gastrointestinal surgery
Chewing gum

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014