Comparative Study of Laparoscopic Versus Open Appendectomy in Children

May 25, 2012 updated by: David Bliss, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Oregon
      • Portland, Oregon, United States, 97227
        • Emanuel Children's Hospital
      • Portland, Oregon, United States, 97227
        • Oregon Health and Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical complications, length of stay, pain medication requirements
Time Frame: within 30 days of intervention
within 30 days of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient/family satisfaction
Time Frame: within 7 days of intervention
within 7 days of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Children's Hospital Los Angeles

Investigators

  • Principal Investigator: David Bliss, M.D., University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 25, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00002184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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