Imaging Possible Appendicitis With CT

NCT03570398 | Completed

• 1 other identifier: 2016040
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Feasibility

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

  2 years

Study Arms (2)

Abdominal CT

OTHER

Other: unenhanced abdomino-pelvic CT scan

Abdominal Ultrasound

OTHER

Other: abdominal ultrasound

Interventions

unenhanced abdomino-pelvic CT scan OTHER

unenhanced abdomino-pelvic CT scan

Abdominal CT

abdominal ultrasound OTHER

abdominal ultrasound

Abdominal Ultrasound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead

Study Sites (1)

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Peter Davis, MD

  James Cook University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 27, 2018
• Study Start: July 15, 2016
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-05

Locations

GB (1)