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
  Purpose

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.


Condition Intervention
Appendicitis
Procedure: laparoscopic appendectomy
Procedure: open appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Surgical complications, length of stay, pain medication requirements [ Time Frame: within 30 days of intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient/family satisfaction [ Time Frame: within 7 days of intervention ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2007
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
children randomized to open appendectomy
Procedure: open appendectomy
open operation for removal of appendix
Active Comparator: 2
children randomized to laparoscopic appendectomy
Procedure: laparoscopic appendectomy
appendix removal via scope

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554008

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97227
Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Oregon Health and Science University
Children's Hospital Los Angeles
Investigators
Principal Investigator: David Bliss, M.D. University of Southern California
  More Information

No publications provided

Responsible Party: David Bliss, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00554008     History of Changes
Other Study ID Numbers: IRB00002184
Study First Received: November 5, 2007
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Appendicitis
laparoscopy
randomized trial
children
pediatric

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014