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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583452
First Posted: April 24, 2012
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery

Further study details as provided by Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time to First Flatus [ Time Frame: End of surgery to first flatus (from 1 to 3 days) ]
    The time between the end of surgery and the moment in which the patient passes first flatus

  • Time to First Bowel Movement [ Time Frame: End of surgery to first bowel motion (from 1 to 7 days) ]
    The time between the end of surgery and the moment in which the patient presents first bowel movement.

  • Time to Tolerate Feedings (Oral Intake) [ Time Frame: End of surgery to oral intake tolerance (from 1 to 3 days) ]
    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: 41
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 3, 2012
First Posted: April 24, 2012
Results First Submitted: March 19, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015

Keywords provided by Gabriela López Jaimez, 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