Initial Versus Delayed Operation for Treatment of Complic... | NCT00540189

Studies
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

NCT00540189

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Dec 19, 2016Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Perforated Appendicitis

Interventions

Initial appendectomy
Interval appendectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to adequatly recruit

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 4, 2007

First Submission Date that Met QC Criteria

Oct 4, 2007

First Posted Date

Oct 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2016

Last Update Posted Date

Dec 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Initial appendectomy	Procedure		Initial appendectomy
Interval appendectomy

Measure	Description	Time Frame
cost effectiveness		3 months post entry into the study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:children

Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

Age <2 and >18
Pregnancy
Immunocompromise

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven W Bruch, MD, MSc	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mott Childrens Hospital		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided