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NCT00540189 Clinical Trial

Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Perforated Appendicitis Clinical Trial

Official title:
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00540189
Other study ID # HUM00007791
Secondary ID
Status Terminated
Phase N/A
First received October 4, 2007
Last updated December 16, 2016
Start date May 2008
Est. completion date January 2010

Study information
Verified date December 2016
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria:children

- Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

- Age <2 and >18

- Pregnancy

- Immunocompromise

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Initial appendectomy

• Interval appendectomy

Locations
Country Name City State
United States Mott Childrens Hospital Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary cost effectiveness 3 months post entry into the study No
See also
  Status Clinical Trial Phase
Completed NCT04512196 - Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution N/A
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
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
Withdrawn NCT00879294 - The Effect of Gum Chewing on Postoperative Ileus N/A