The Effect of Gum Chewing on Postoperative Ileus
Primary Purpose
Perforated Appendicitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motion sickness wristband
Chewing Gum
Sponsored by
About this trial
This is an interventional supportive care trial for Perforated Appendicitis focused on measuring Perforated appendicitis, Ruptured appendicitis, Acute appendicitis with perforation
Eligibility Criteria
Inclusion Criteria:
- any child who has undergone appendectomy for perforated appendicitis
Exclusion Criteria:
- age less than or equal to 5 years
- unable to chew gum safely
- interval appendectomy
Sites / Locations
- Brenner Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
No Intervention
Arm Label
1 Wristband
Chewing Gum
Control
Arm Description
Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.
Patients will be randomized to use chewing gum after surgery.
Usual post-operative care.
Outcomes
Primary Outcome Measures
Time to resolution of post-operative ileus.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00879294
Brief Title
The Effect of Gum Chewing on Postoperative Ileus
Official Title
The Effect of Gum Chewing on Postoperative Ileus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.
Detailed Description
After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Appendicitis
Keywords
Perforated appendicitis, Ruptured appendicitis, Acute appendicitis with perforation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Wristband
Arm Type
Sham Comparator
Arm Description
Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.
Arm Title
Chewing Gum
Arm Type
Experimental
Arm Description
Patients will be randomized to use chewing gum after surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual post-operative care.
Intervention Type
Device
Intervention Name(s)
Motion sickness wristband
Intervention Description
No drugs are involved.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewing Gum
Intervention Description
Patients will be asked to chew gum for 20 minutes, four times daily.
Primary Outcome Measure Information:
Title
Time to resolution of post-operative ileus.
Time Frame
1-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any child who has undergone appendectomy for perforated appendicitis
Exclusion Criteria:
age less than or equal to 5 years
unable to chew gum safely
interval appendectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pranikoff, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brenner Children's Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Gum Chewing on Postoperative Ileus
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