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Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laparoscopic appendectomy
open appendectomy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, laparoscopy, randomized trial, children, pediatric

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Los Angeles
  • Emanuel Children's Hospital
  • Oregon Health and Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

children randomized to open appendectomy

children randomized to laparoscopic appendectomy

Outcomes

Primary Outcome Measures

Surgical complications, length of stay, pain medication requirements

Secondary Outcome Measures

Patient/family satisfaction

Full Information

First Posted
November 5, 2007
Last Updated
May 25, 2012
Sponsor
Oregon Health and Science University
Collaborators
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00554008
Brief Title
Comparative Study of Laparoscopic Versus Open Appendectomy in Children
Official Title
Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Children's Hospital Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendicitis, laparoscopy, randomized trial, children, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
children randomized to open appendectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
children randomized to laparoscopic appendectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic appendectomy
Intervention Description
appendix removal via scope
Intervention Type
Procedure
Intervention Name(s)
open appendectomy
Intervention Description
open operation for removal of appendix
Primary Outcome Measure Information:
Title
Surgical complications, length of stay, pain medication requirements
Time Frame
within 30 days of intervention
Secondary Outcome Measure Information:
Title
Patient/family satisfaction
Time Frame
within 7 days of intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bliss, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Emanuel Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Laparoscopic Versus Open Appendectomy in Children

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