Post Operative Ileus Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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