NCT00554008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

November 5, 2007

Last Update Submit

May 25, 2012

Conditions

Appendicitis

Keywords

Appendicitislaparoscopyrandomized trialchildrenpediatric

Outcome Measures

Primary Outcomes (1)

  • Surgical complications, length of stay, pain medication requirements

    within 30 days of intervention

Secondary Outcomes (1)

  • Patient/family satisfaction

    within 7 days of intervention

Study Arms (2)

1

ACTIVE COMPARATOR

children randomized to open appendectomy

Procedure: open appendectomy

2

ACTIVE COMPARATOR

children randomized to laparoscopic appendectomy

Procedure: laparoscopic appendectomy

Interventions

laparoscopic appendectomyPROCEDURE

appendix removal via scope

2
open appendectomyPROCEDURE

open operation for removal of appendix

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All children under the age of 18 years with diagnosed appendicitis

You may not qualify if:

  • Refusal of consent
  • Primary language other than English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • David Bliss, M.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

December 1, 2007

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(3)