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Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

NCT ID: NCT00540189

Last Updated: 2016-12-19

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

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perforated Appendicitis

Keywords

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appendicitis, perforated, children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Initial appendectomy

children with complicated appendicitis will undergo initial appendectomy

Group Type OTHER

Initial appendectomy

Intervention Type PROCEDURE

Interval appendectomy

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

Group Type OTHER

Interval appendectomy

Intervention Type PROCEDURE

Interventions

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Initial appendectomy

Intervention Type PROCEDURE

Interval appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria

* Age \<2 and \>18
* Pregnancy
* Immunocompromise
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Steven W. Bruch

Clinical Assoicate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven W Bruch, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Mott Childrens Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00007791

Identifier Type: -

Identifier Source: org_study_id