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Comparative Study of Laparoscopic Versus Open Appendectomy in Children

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
David Bliss, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00554008
First received: November 5, 2007
Last updated: May 25, 2012
Last verified: May 2012

November 5, 2007
May 25, 2012
December 2007
December 2010   (final data collection date for primary outcome measure)
Surgical complications, length of stay, pain medication requirements [ Time Frame: within 30 days of intervention ] [ Designated as safety issue: Yes ]
Surgical complications Length of stay Pain medication requirements [ Time Frame: within 30 days of intervention ]
Complete list of historical versions of study NCT00554008 on ClinicalTrials.gov Archive Site
Patient/family satisfaction [ Time Frame: within 7 days of intervention ] [ Designated as safety issue: No ]
Patient/family satisfaction [ Time Frame: within 7 days of intervention ]
Not Provided
Not Provided
 
Comparative Study of Laparoscopic Versus Open Appendectomy in Children
Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Appendicitis
  • Procedure: laparoscopic appendectomy
    appendix removal via scope
  • Procedure: open appendectomy
    open operation for removal of appendix
  • Active Comparator: 1
    children randomized to open appendectomy
    Intervention: Procedure: open appendectomy
  • Active Comparator: 2
    children randomized to laparoscopic appendectomy
    Intervention: Procedure: laparoscopic appendectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554008
IRB00002184
Yes
David Bliss, Oregon Health and Science University
Oregon Health and Science University
Children's Hospital Los Angeles
Principal Investigator: David Bliss, M.D. University of Southern California
Oregon Health and Science University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP