NCT00540189

Brief Summary

To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

October 4, 2007

Last Update Submit

December 16, 2016

Conditions

Perforated Appendicitis

Keywords

appendicitis, perforated, children

Outcome Measures

Primary Outcomes (1)

  • cost effectiveness

    3 months post entry into the study

Study Arms (2)

Initial appendectomy

OTHER

children with complicated appendicitis will undergo initial appendectomy

Procedure: Initial appendectomy

Interval appendectomy

OTHER

children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy

Procedure: Interval appendectomy

Interventions

Initial appendectomyPROCEDURE
Initial appendectomy
Interval appendectomyPROCEDURE
Interval appendectomy

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-17 with a diagnosis of perforated appendicitis

You may not qualify if:

  • Age \<2 and \>18
  • Pregnancy
  • Immunocompromise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mott Childrens Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Steven W Bruch, MD, MSc

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assoicate Professor

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations

US(1)