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

Primary Purpose

Post Operative Ileus

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Chewing Gum
Sponsored by
Instituto Tecnologico y de Estudios Superiores de Monterey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Ileus focused on measuring Post operative ileus, Gastrointestinal surgery, Chewing gum

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital San Jose Tec de Monterrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chewing Gum Group

No intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Post-Operative Hospital Stay
The time between the end of surgery and hospital discharge, measured in hours

Secondary Outcome Measures

Time to First Flatus
The time between the end of surgery and the moment in which the patient passes first flatus
Time to First Bowel Movement
The time between the end of surgery and the moment in which the patient presents first bowel movement.
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.

Full Information

First Posted
April 3, 2012
Last Updated
June 27, 2015
Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
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1. Study Identification

Unique Protocol Identification Number
NCT01583452
Brief Title
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
Official Title
Use of Chewing Gum to Reduce Postoperative Ileus in Pediatric Patients After Gastrointestinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Ileus
Keywords
Post operative ileus, Gastrointestinal surgery, Chewing gum

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chewing Gum Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chewing Gum
Other Intervention Name(s)
Sugarless chewing gum, Trident, Orbit, Ice Breakers, Smint
Intervention Description
The use of chewing gum as a preventive measure for post-operative ileus
Primary Outcome Measure Information:
Title
Post-Operative Hospital Stay
Description
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)
Secondary Outcome Measure Information:
Title
Time to First Flatus
Description
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)
Title
Time to First Bowel Movement
Description
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)
Title
Time to Tolerate Feedings (Oral Intake)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela Lopez, MD
Organizational Affiliation
Instituto Tecnologico y de Estudios Superiores de Monterey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Jose Tec de Monterrey
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19050983
Citation
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.
Results Reference
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PubMed Identifier
19884293
Citation
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.
Results Reference
background
PubMed Identifier
18711040
Citation
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.
Results Reference
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PubMed Identifier
18292660
Citation
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.
Results Reference
background
PubMed Identifier
19261555
Citation
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.
Results Reference
background
PubMed Identifier
19763686
Citation
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.
Results Reference
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Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients

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