Clinical trial NCT03570398: Imaging Possible Appendicitis With CT
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
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
Study officials:
affiliation: James Cook University Hospital
name: Peter Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: