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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing Gum Group | Experimental | 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. |
|
| No intervention | No Intervention | By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewing Gum | Other | The use of chewing gum as a preventive measure for post-operative ileus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Hospital Stay | The time between the end of surgery and hospital discharge, measured in hours | End of surgery to hospital discharge (from 4 to 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Flatus | The time between the end of surgery and the moment in which the patient passes first flatus | End of surgery to first flatus (from 1 to 3 days) |
| Time to First Bowel Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Lopez, MD | Instituto Tecnologico y de Estudios Superiores de Monterey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Jose Tec de Monterrey | Monterrey | Nuevo León | 64710 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19050983 | Background | Vasquez W, Hernandez AV, Garcia-Sabrido JL. Is gum chewing useful for ileus after elective colorectal surgery? A systematic review and meta-analysis of randomized clinical trials. J Gastrointest Surg. 2009 Apr;13(4):649-56. doi: 10.1007/s11605-008-0756-8. Epub 2008 Dec 3. | |
| 19884293 | Background | Johnson MD, Walsh RM. Current therapies to shorten postoperative ileus. Cleve Clin J Med. 2009 Nov;76(11):641-8. doi: 10.3949/ccjm.76a.09051. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chewing Gum Group | Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus |
| FG001 | No Intervention | By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-Operative Hospital Stay | The time between the end of surgery and hospital discharge, measured in hours | 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. | Posted | Mean | Standard Deviation | hours | End of surgery to hospital discharge (from 4 to 7 days) |
|
During the 5 months in which data was collected
One patient accidentally swallowed the gum without any clinical signs or complications, however with risk of intestinal obstruction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chewing Gum Group | Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swallowing of chewing gum | Gastrointestinal disorders | Swallowgum | Non-systematic Assessment | One of the patients in the intervention group accidentally swallowed the gum without any clinical implications, however with risk of intestinal obstruction |
We had a small number of participants because of time limitations. We included only patients with diagnosis of appendicitis and post-op appendectomy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriela López Jaimez | ITESM - Pediatrics Division | +527211476044 | gabylopez7@gmail.com |
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D000072278 | Forkhead Box Protein M1 |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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The time between the end of surgery and the moment in which the patient presents first bowel movement.
| End of surgery to first bowel motion (from 1 to 7 days) |
| 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. | End of surgery to oral intake tolerance (from 1 to 3 days) |
| 18711040 | Background | Purkayastha S, Tilney HS, Darzi AW, Tekkis PP. Meta-analysis of randomized studies evaluating chewing gum to enhance postoperative recovery following colectomy. Arch Surg. 2008 Aug;143(8):788-93. doi: 10.1001/archsurg.143.8.788. |
| 18292660 | Background | de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21. |
| 19261555 | Background | Noble EJ, Harris R, Hosie KB, Thomas S, Lewis SJ. Gum chewing reduces postoperative ileus? A systematic review and meta-analysis. Int J Surg. 2009 Apr;7(2):100-5. doi: 10.1016/j.ijsu.2009.01.006. Epub 2009 Jan 31. |
| 19763686 | Background | Fitzgerald JE, Ahmed I. Systematic review and meta-analysis of chewing-gum therapy in the reduction of postoperative paralytic ileus following gastrointestinal surgery. World J Surg. 2009 Dec;33(12):2557-66. doi: 10.1007/s00268-009-0104-5. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Time to First Flatus | The time between the end of surgery and the moment in which the patient passes first flatus | 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. | Posted | Mean | Standard Deviation | hours | End of surgery to first flatus (from 1 to 3 days) |
|
|
|
|
| Secondary | Time to First Bowel Movement | The time between the end of surgery and the moment in which the patient presents first bowel movement. | 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. | Posted | Mean | Standard Deviation | hours | End of surgery to first bowel motion (from 1 to 7 days) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hours | End of surgery to oral intake tolerance (from 1 to 3 days) |
|
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | No Intervention | By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care. | 0 | 20 | 0 | 20 |
|
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D051858 | Forkhead Transcription Factors |
| D051540 | Winged-Helix Transcription Factors |
| D004268 | DNA-Binding Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014157 | Transcription Factors |