Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
Condition: Post Operative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Chewing Gum
Intervention type(s): Other
Intervention description(s): The use of chewing gum as a preventive measure for post-operative ileus
Other intervention name(s): Sugarless chewing gum; Trident; Orbit; Ice Breakers; Smint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Post operative ileus; Gastrointestinal surgery; Chewing gum