Comparative Study of Laparoscopic Versus Open Appendectomy in Children

NCT ID: NCT00554008

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

children randomized to open appendectomy

Group Type ACTIVE_COMPARATOR

open appendectomy

Intervention Type PROCEDURE

open operation for removal of appendix

2

children randomized to laparoscopic appendectomy

Group Type ACTIVE_COMPARATOR

laparoscopic appendectomy

Intervention Type PROCEDURE

appendix removal via scope

Interventions

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laparoscopic appendectomy

appendix removal via scope

Intervention Type PROCEDURE

open appendectomy

open operation for removal of appendix

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Bliss

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Bliss, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Emanuel Children's Hospital

Portland, Oregon, United States

Site Status

Oregon Health and Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00002184

Identifier Type: -

Identifier Source: org_study_id

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