HerniaNCT03121131
CT and Radiologist RCT
A study testing Clinical Exam Findings, Inaccurate Clinical Exam Findings and No clinical exam findings in people with Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia
- What is being tested?
- Clinical Exam Findings, Inaccurate Clinical Exam Findings and No clinical exam findings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 10 Apr 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants are radiologists at LBJ Hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health at Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
Official title: How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors.
The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.
- Conditions
- Hernia
- Being tested
- Clinical Exam Findings, Inaccurate Clinical Exam Findings, No clinical exam findings
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Exam FindingsOther
Findings found on clinical exam of a patient the radiologist will be reading CT scans of.
Inaccurate Clinical Exam FindingsOther
Inaccurate findings are given to the radiologists
No clinical exam findingsOther
No clinical exam findings are given to the radiologists
| Study group | Role | What they receive |
|---|---|---|
| Accurate Clinical Exam Findings | Other | Radiologists will be provided with accurate clinical exam data. Receives: Other: Clinical Exam Findings |
| Inaccurate Clinical Exam Findings | Other | Radiologists will be provided with purposefully incorrect clinical exam data Receives: Other: Inaccurate Clinical Exam Findings |
| No Clinical Exam Findings | Other | Radiologists will be not be provided with any clinical exam data Receives: Other: No clinical exam findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia detected on CT
proportion of hernias detected on CT
Measured: CT taken within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start5 May 2017
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike K Liang, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121131
- Sponsor's protocol ID
- HSC-MS-17-0277
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2017
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cherla DV, Bernardi K, Blair KJ, Chua SS, Hasapes JP, Kao LS, Ko TC, Matta EJ, Moses ML, Shiralkar KG, Surabhi VR, Tammisetti VS, Viso CP, Liang MK. Importance of the physical exam: double-blind randomized controlled trial of radiologic interpretation of ventral hernias after selective clinical information. Hernia. 2019 Oct;23(5):987-994. doi: 10.1007/s10029-018-1856-3. Epub 2018 Nov 14.
PubMed 30430273
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information
- ClinicalTrials.gov ID
- NCT03121131
- Acronym / sponsor ID
- HSC-MS-17-0277
- Conditions
- Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 19 Apr 2017 (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.
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors.
The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Accurate Clinical Exam Findings | Other | Other: Clinical Exam FindingsRadiologists will be provided with accurate clinical exam data. |
| Inaccurate Clinical Exam Findings | Other | Other: Inaccurate Clinical Exam FindingsRadiologists will be provided with purposefully incorrect clinical exam data |
| No Clinical Exam Findings | Other | Other: No clinical exam findingsRadiologists will be not be provided with any clinical exam data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Clinical Exam FindingsFindings found on clinical exam of a patient the radiologist will be reading CT scans of. | Other | Accurate Clinical Exam Findings |
| Inaccurate Clinical Exam FindingsInaccurate findings are given to the radiologists | Other | Inaccurate Clinical Exam Findings |
| No clinical exam findingsNo clinical exam findings are given to the radiologists | Other | No Clinical Exam Findings |
Primary outcome
Hernia detected on CT
Time frame: CT taken within 1 year
proportion of hernias detected on CT
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 13 Apr 2020.
- Derived from this study: PubMed 30430273Cherla DV, Bernardi K, Blair KJ, Chua SS, Hasapes JP, Kao LS, Ko TC, Matta EJ, Moses ML, Shiralkar KG, Surabhi VR, Tammisetti VS, Viso CP, Liang MK. Importance of the physical exam: double-blind randomized controlled trial of radiologic interpretation of ventral hernias after selective clinical information. Hernia. 2019 Oct;23(5):987-994. doi: 10.1007/s10029-018-1856-3. Epub 2018 Nov 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Exam Findings, Inaccurate Clinical Exam Findings and No clinical exam findings in people with Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Apr 2020. 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 States. 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?
Hernia detected on CT (time frame: CT taken within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121131, which also lists 1 linked publication.
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 13 Apr 2020.