Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Appendicitis Clinical Trial

Official title:

Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554008
• Other study ID #: IRB00002184
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: May 25, 2012
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: May 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.

The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All children under the age of 18 years with diagnosed appendicitis

Exclusion Criteria:

• Refusal of consent

• Primary language other than English or Spanish.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• laparoscopic appendectomy
appendix removal via scope
• open appendectomy
open operation for removal of appendix

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Emanuel Children's Hospital	Portland	Oregon
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical complications, length of stay, pain medication requirements		within 30 days of intervention	Yes
Secondary	Patient/family satisfaction		within 7 days of intervention	No