Impact of CT on Diagnosis of Acute Appendicitis | NCT01376466

Studies
Impact of CT on Diagnosis of Acute Appendicitis

NCT01376466

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 9, 2012Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Acute Appendicitis

Interventions

CT scanning

Countries

Denmark

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

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jun 17, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

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

Nov 8, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Name	Class
Herning Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.

Detailed Description

The aim of this study is to

evaluate CT scan validity for the diagnosis of acute appendicitis.
compare the difference in evaluation of CT-scan result between radiologist on call and consultant radiologist with CT experience.
illustrate difficulties associated with practical implementation of CT-scan in relation to other activities in radiology department and O.R. (logical & organizational).
illustrate patients experiences about the study (pain, discomfort & other information

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with acute appendicitis		Patients who have been clinically diagnosed to have acute appendicitis	Other: CT scanning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT scanning	Other	CT image of the abdomen included the area between the 3rd. lumber vertebra and the top of acetabulum. A liter of contrast mixed with normal salin will be given by rectal catheter 20 minutes before CT image is taken.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been admitted and diagnosed as having acute appendicitis

Exclusion Criteria:

Patients under the age of 18 years.
Pregnancy.
Uncooperative patients (senile dementia, mentally ill).
Not speaking Danish.
Does not wish to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Admitted patients with acute appendicitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mogens R Madsen, MD	Consultant surgeon	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herning Hospital		Herning	Herning	7400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis
D004194	Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided