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

Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01583452
Enrollment
41
Registered
2012-04-24
Start date
2012-04-30
Completion date
2012-09-30
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Ileus

Keywords

Post operative ileus, Gastrointestinal surgery, Chewing gum

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.

Interventions

OTHERChewing Gum

The use of chewing gum as a preventive measure for post-operative ileus

Sponsors

Instituto Tecnologico y de Estudios Superiores de Monterey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-Operative Hospital StayEnd of surgery to hospital discharge (from 4 to 7 days)The time between the end of surgery and hospital discharge, measured in hours

Secondary

MeasureTime frameDescription
Time to First FlatusEnd 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 MovementEnd 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.

Countries

Mexico

Participant flow

Recruitment details

Our study included 5-18 years old patients with gastrointestinal surgery from two institutions (Hospital San José Tec de Monterrey and Hospital Regional Materno Infantil); during April to August 2012. However, because the most common diagnosis in this group of age was appendicitis, only patients with this condition were included at the end.

Pre-assignment details

Initially our study was focused on patients who had gastrointestinal surgery, however, the main diagnosis of our population of interest was appendicitis; and those children with other diagnosis did not meet the criteria for including them in the study. This way, our final population was children who underwent open or laparoscopic appendectomy.

Participants by arm

ArmCount
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. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus
21
No Intervention
By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
20
Total41

Baseline characteristics

CharacteristicChewing Gum GroupNo InterventionTotal
Age, Continuous9.5 years8.6 years9.2 years
Region of Enrollment
Mexico
21 participants20 participants41 participants
Sex: Female, Male
Female
7 Participants5 Participants12 Participants
Sex: Female, Male
Male
14 Participants15 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 210 / 20
serious
Total, serious adverse events
0 / 210 / 20

Outcome results

Primary

Post-Operative Hospital Stay

The time between the end of surgery and hospital discharge, measured in hours

Time frame: End of surgery to hospital discharge (from 4 to 7 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

ArmMeasureValue (MEAN)Dispersion
Chewing Gum GroupPost-Operative Hospital Stay79.93 hoursStandard Deviation 50.76
Control GroupPost-Operative Hospital Stay72.94 hoursStandard Deviation 28.33
Comparison: With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.p-value: 0.665Kaplan-Meier survival analysis
Secondary

Time to First Bowel Movement

The time between the end of surgery and the moment in which the patient presents first bowel movement.

Time frame: End of surgery to first bowel motion (from 1 to 7 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

ArmMeasureValue (MEAN)Dispersion
Chewing Gum GroupTime to First Bowel Movement29.91 hoursStandard Deviation 21.27
Control GroupTime to First Bowel Movement34.5 hoursStandard Deviation 22.78
p-value: 0.059Kaplan-Meier survival analysis
Secondary

Time to First Flatus

The time between the end of surgery and the moment in which the patient passes first flatus

Time frame: End of surgery to first flatus (from 1 to 3 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

ArmMeasureValue (MEAN)Dispersion
Chewing Gum GroupTime to First Flatus17.18 hoursStandard Deviation 8.18
Control GroupTime to First Flatus24.37 hoursStandard Deviation 1.53
p-value: 0.094Kaplan-Meier survival analysis
Secondary

Time to Tolerate Feedings (Oral Intake)

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.

Time frame: End of surgery to oral intake tolerance (from 1 to 3 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

ArmMeasureValue (MEAN)Dispersion
Chewing Gum GroupTime to Tolerate Feedings (Oral Intake)31.21 hoursStandard Deviation 25.46
Control GroupTime to Tolerate Feedings (Oral Intake)27.04 hoursStandard Deviation 15.51
p-value: 0.83Kaplan-Meier survival analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026