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

Phase 1

Completed

Conditions: Post Operative Ileus

Interventions: Other: Chewing Gum

Registration Number: NCT01583452

Lead Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing Gum Group	Chewing Gum	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.

Primary Outcome Measures

Name	Time	Method
Post-Operative Hospital Stay	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

Name	Time	Method
Time to First Flatus	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	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)	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.