Trial Outcomes & Findings for Magnetic Resonance Imaging (MRI) of Appendicitis in Children (NCT NCT00723788)

Results Overview

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

during diagnostic procedure

Results posted on

2014-11-21

Participant Flow

Patient referral from Emergency Department for suspected appendicitis with ultrasound and/or CT imaging request (0800 hr - 1700 hr) Patients accrued from Aug 2008 - Apr 2010

Participant milestones

Participant milestones
Measure	MRI of the Abdomen All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI of the Abdomen n=21 Participants All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
Age, Categorical <=18 years	21 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United States	21 participants n=93 Participants

PRIMARY outcome

Timeframe: during diagnostic procedure

Population: All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)

Outcome measures

Outcome measures
Measure	MRI of the Abdomen n=21 Participants All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.	US of the Abdomen n=20 Participants All patients enrolled received an MRI followed in some cases by ultrasund.	CT of the Abdomen n=9 Participants All patients enrolled received an MRI followed in some cases by computed tomography.
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up Sensitivity	13 participants	17 participants	4 participants
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up Specificity	19 participants	20 participants	7 participants
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up PPV	17 participants	20 participants	4 participants
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up NPV	16 participants	18 participants	7 participants

Adverse Events

MRI of the Abdomen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pranav Vyas, MD

Children's National Health System

Phone: 2024760186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place