Imaging Possible Appendicitis With CT

Abdominal Pain Clinical Trial

— IMPACT  

Official title:

A Feasibility Randomised Control Trial to Evaluate the Role of Computed Tomography in Patients With Indeterminate Right Iliac Fossa Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570398
• Other study ID #: 2016040
• Status: Completed
• Phase: N/A
• Start date: July 15, 2016
• Est. completion date: February 14, 2018

Study information

• Verified date: May 2018
• Source: South Tees Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Other:
• unenhanced abdomino-pelvic CT scan
unenhanced abdomino-pelvic CT scan
• abdominal ultrasound
abdominal ultrasound

Locations

Country	Name	City	State
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
South Tees Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	As assessed by the rate of refusal to participate amongst eligible patients	2 years