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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier:
NCT01583452
First received: April 3, 2012
Last updated: June 27, 2015
Last verified: June 2015
Results First Received: March 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Post Operative Ileus
Intervention: Other: Chewing Gum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

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.

Participant Flow:   Overall Study
    Chewing Gum Group     No Intervention  
STARTED     21     20  
COMPLETED     21     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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.
Total Total of all reporting groups

Baseline Measures
    Chewing Gum Group     No Intervention     Total  
Number of Participants  
[units: participants]
  21     20     41  
Age  
[units: years]
Mean (Inter-Quartile Range)
  9.5   (7.5 to 12)     8.6   (6 to 11.5)     9.2   (6 to 12)  
Gender  
[units: participants]
     
Female     7     5     12  
Male     14     15     29  
Region of Enrollment  
[units: participants]
     
Mexico     21     20     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post-Operative Hospital Stay   [ Time Frame: End of surgery to hospital discharge (from 4 to 7 days) ]

2.  Secondary:   Time to First Flatus   [ Time Frame: End of surgery to first flatus (from 1 to 3 days) ]

3.  Secondary:   Time to First Bowel Movement   [ Time Frame: End of surgery to first bowel motion (from 1 to 7 days) ]

4.  Secondary:   Time to Tolerate Feedings (Oral Intake)   [ Time Frame: End of surgery to oral intake tolerance (from 1 to 3 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We had a small number of participants because of time limitations. We included only patients with diagnosis of appendicitis and post-op appendectomy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gabriela López Jaimez
Organization: ITESM - Pediatrics Division
phone: +527211476044
e-mail: gabylopez7@gmail.com


Publications:

Responsible Party: Gabriela López Jaimez, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT01583452     History of Changes
Other Study ID Numbers: UGoMaRIPO
Study First Received: April 3, 2012
Results First Received: March 19, 2015
Last Updated: June 27, 2015
Health Authority: Mexico: Ethics Committee