Imaging Possible Appendicitis With CT

NCT ID: NCT03570398

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-15
• Study Completion Date: 2018-02-14

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.

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Abdominal CT

Group Type: OTHER

unenhanced abdomino-pelvic CT scan

Intervention Type: OTHER

unenhanced abdomino-pelvic CT scan

Abdominal Ultrasound

Group Type: OTHER

abdominal ultrasound

Intervention Type: OTHER

abdominal ultrasound

Interventions

unenhanced abdomino-pelvic CT scan

unenhanced abdomino-pelvic CT scan

Intervention Type: OTHER

abdominal ultrasound

abdominal ultrasound

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Davis, MD

Role: PRINCIPAL_INVESTIGATOR

James Cook University Hospital

Locations

South Tees Hospitals NHS Foundation Trust

Middlesbrough, , United Kingdom

Countries

United Kingdom

Other Identifiers

2016040

Identifier Type: -

Identifier Source: org_study_id