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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00879294
Other study ID # CR1_IRB00005677
Secondary ID
Status Withdrawn
Phase N/A
First received April 9, 2009
Last updated November 2, 2017

Study information

Verified date July 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Motion sickness wristband
No drugs are involved.
Dietary Supplement:
Chewing Gum
Patients will be asked to chew gum for 20 minutes, four times daily.

Locations

Country Name City State
United States Brenner Children's Hospital Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to resolution of post-operative ileus. 1-14 days
See also
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Not yet recruiting NCT03267082 - Evaluation the Role of Laparoscopic Management of Perforated Appendicitis N/A
Completed NCT00528138 - Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation N/A
Completed NCT03289351 - Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis Phase 4
Recruiting NCT00677989 - Study on Laparoscopic Operation for Perforated Appendicitis N/A
Terminated NCT00540189 - Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children N/A
Completed NCT00677417 - Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis N/A
Terminated NCT03795194 - Antibiotic Duration in Post-appendectomy Abscess Phase 4
Completed NCT00462020 - Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis N/A
Completed NCT04472052 - Frequency of Perforated Appendicitis in Times of COVID-19
Completed NCT03159754 - Optimal Care of Complicated Appendicitis Phase 4
Completed NCT02881996 - The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis N/A
Active, not recruiting NCT04039750 - Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis Phase 2
Completed NCT02724410 - Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis N/A
Recruiting NCT04253899 - The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations N/A
Completed NCT00854815 - Irrigation Versus No Irrigation for Perforated Appendicitis N/A
Completed NCT00195923 - Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis Phase 4