Post Operative Ileus
Conditions
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
The use of chewing gum as a preventive measure for post-operative ileus
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 41 |
Baseline characteristics
| Characteristic | Chewing Gum Group | No Intervention | Total |
|---|---|---|---|
| Age, Continuous | 9.5 years | 8.6 years | 9.2 years |
| Region of Enrollment Mexico | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chewing Gum Group | Post-Operative Hospital Stay | 79.93 hours | Standard Deviation 50.76 |
| Control Group | Post-Operative Hospital Stay | 72.94 hours | Standard Deviation 28.33 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chewing Gum Group | Time to First Bowel Movement | 29.91 hours | Standard Deviation 21.27 |
| Control Group | Time to First Bowel Movement | 34.5 hours | Standard Deviation 22.78 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chewing Gum Group | Time to First Flatus | 17.18 hours | Standard Deviation 8.18 |
| Control Group | Time to First Flatus | 24.37 hours | Standard Deviation 1.53 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chewing Gum Group | Time to Tolerate Feedings (Oral Intake) | 31.21 hours | Standard Deviation 25.46 |
| Control Group | Time to Tolerate Feedings (Oral Intake) | 27.04 hours | Standard Deviation 15.51 |