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Comparative Study of Laparoscopic Versus Open Appendectomy in Children

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ClinicalTrials.gov Identifier: NCT00554008
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Appendicitis Procedure: laparoscopic appendectomy Procedure: open appendectomy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
Study Start Date : December 2007
Primary Completion Date : December 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Surgical complications, length of stay, pain medication requirements [ Time Frame: within 30 days of intervention ]

Secondary Outcome Measures :
  1. Patient/family satisfaction [ Time Frame: within 7 days of intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554008

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

Responsible Party: David Bliss, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00554008     History of Changes
Other Study ID Numbers: IRB00002184
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by David Bliss, Oregon Health and Science University:
randomized trial

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases