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Imaging Possible Appendicitis With CT (IMPACT)

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
unenhanced abdomino-pelvic CT scan
abdominal ultrasound
Sponsored by
South Tees Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Tees Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Abdominal CT

Abdominal Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Feasibility
As assessed by the rate of refusal to participate amongst eligible patients

Secondary Outcome Measures

Full Information

First Posted
May 25, 2018
Last Updated
June 15, 2018
Sponsor
South Tees Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03570398
Brief Title
Imaging Possible Appendicitis With CT
Acronym
IMPACT
Official Title
A Feasibility Randomised Control Trial to Evaluate the Role of Computed Tomography in Patients With Indeterminate Right Iliac Fossa Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
February 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Tees Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominal CT
Arm Type
Other
Arm Title
Abdominal Ultrasound
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
unenhanced abdomino-pelvic CT scan
Intervention Description
unenhanced abdomino-pelvic CT scan
Intervention Type
Other
Intervention Name(s)
abdominal ultrasound
Intervention Description
abdominal ultrasound
Primary Outcome Measure Information:
Title
Feasibility
Description
As assessed by the rate of refusal to participate amongst eligible patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Davis, MD
Organizational Affiliation
James Cook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom

12. IPD Sharing Statement

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Imaging Possible Appendicitis With CT

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