Imaging Possible Appendicitis With CT | NCT03570398

Studies
Imaging Possible Appendicitis With CT

NCT03570398

Sponsor

South Tees Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Abdominal Pain

Interventions

unenhanced abdomino-pelvic CT scan
abdominal ultrasound

Countries

United Kingdom

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

May 2018

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

Jul 15, 2016Actual

Primary Completion Date

Feb 14, 2018Actual

Completion Date

Feb 14, 2018Actual

First Submitted Date

May 25, 2018

First Submission Date that Met QC Criteria

Jun 15, 2018

First Posted Date

Jun 27, 2018Actual

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

Jun 15, 2018

Last Update Posted Date

Jun 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Pain in the right lower abdomen is one of the commonest reasons patients present to general surgeons as an emergency. Whether or not such patients have appendicitis is crucial to their assessment. In UK practice, when the diagnosis is unclear, ultrasound scanning (US) is commonly used to investigate the problem. US is very safe but it will only visualise the appendix in the minority of cases. As a result, the sensitivity for diagnosing appendicitis in this setting is probably only 5-30%. Alternatively, computed tomography (CT) is an accurate way of diagnosing appendicitis in over 90% of cases. CT scans are readily available and with modern scanners, high quality images can be achieved with lower radiation doses. Unenhanced scanning avoids the use of contrast media and permits further reductions in ionising radiation exposure.

Detailed Description

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal CT	Other		Other: unenhanced abdomino-pelvic CT scan
Abdominal Ultrasound	Other		Other: abdominal ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
unenhanced abdomino-pelvic CT scan	Other	unenhanced abdomino-pelvic CT scan	Abdominal CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility	As assessed by the rate of refusal to participate amongst eligible patients	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Acute presentation with abdominal pain and/or tenderness which is most marked in the right lower abdomen

Exclusion Criteria:

Age<18
Age>60
Pregnancy
Patients with a firm clinical diagnosis of appendicitis where surgical management is indicated at presentation
Patients who have undergone CT scanning within the past two months
Patients with cognitive impairment who would lack capacity to give consent
Inability to understand written or spoken English
Patients who have previously undergone appendicectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Davis, MD	James Cook University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Tees Hospitals NHS Foundation Trust		Middlesbrough		TS4 3BW	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided