Abdominal PainIMPACTNCT03570398
Imaging Possible Appendicitis With CT
A study testing unenhanced abdomino-pelvic CT scan and abdominal ultrasound in people with Abdominal Pain, run by South Tees Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- unenhanced abdomino-pelvic CT scan and abdominal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2016to 14 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute presentation with abdominal pain and/or tenderness which is most marked in the right lower abdomen
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
About this study
Official title: A Feasibility Randomised Control Trial to Evaluate the Role of Computed Tomography in Patients With Indeterminate Right Iliac Fossa Pain
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.
Read the 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
- Being tested
- unenhanced abdomino-pelvic CT scan, abdominal ultrasound
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unenhanced abdomino-pelvic CT scanOther
unenhanced abdomino-pelvic CT scan
abdominal ultrasoundOther
abdominal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Abdominal CT | Other | Not described Receives: Other: unenhanced abdomino-pelvic CT scan |
| Abdominal Ultrasound | Other | Not described Receives: Other: abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
As assessed by the rate of refusal to participate amongst eligible patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start15 Jul 2016
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Davis, MD, Principal investigator, James Cook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570398
- Sponsor's protocol ID
- 2016040
- Acronym
- IMPACT
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Control Trial to Evaluate the Role of Computed Tomography in Patients With Indeterminate Right Iliac Fossa Pain
- ClinicalTrials.gov ID
- NCT03570398
- Acronym / sponsor ID
- IMPACT / 2016040
- Conditions
- Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal CT | Other | Other: unenhanced abdomino-pelvic CT scan |
| Abdominal Ultrasound | Other | Other: abdominal ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Acute presentation with abdominal pain and/or tenderness which is most marked in the right lower abdomen
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unenhanced abdomino-pelvic CT scanunenhanced abdomino-pelvic CT scan | Other | Abdominal CT |
| abdominal ultrasoundabdominal ultrasound | Other | Abdominal Ultrasound |
Primary outcome
Feasibility
Time frame: 2 years
As assessed by the rate of refusal to participate amongst eligible patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Davis, MD principal investigator
James Cook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unenhanced abdomino-pelvic CT scan and abdominal ultrasound in people with Abdominal Pain, run by South Tees Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.