Hernia, InguinalNCT02939443
Prone-position CT for Diagnosing Inguinal Hernia
A study testing supine- and prone-position Computed Tomography in people with Hernia, Inguinal, run by Nagareyama Central Hospital.
Trial summary
Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- supine- and prone-position Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2016
- 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inguinal hernia
Who cannot join
- emergency surgery for incarcerated hernia
- femoral hernia
- recurrent inguinal hernia after laparoscopic inguinal hernia repair
About this study
Official title: Diagnosis of Inguinal Hernia by Prone- vs. Supine-position Computed Tomography
Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair.
Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine and prone positions for preoperative assessment. The anatomy of the right and left inguinal regions was confirmed during the surgery and compared with the preoperative CT findings.
- Conditions
- Hernia, Inguinal
- Being tested
- supine- and prone-position Computed Tomography
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine- and prone-position Computed TomographyRadiation
| Study group | Role | What they receive |
|---|---|---|
| cross-sectional study | Other | Not described Receives: Radiation: supine- and prone-position Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of inguinal hernia
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagareyama Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Miyaki, Nagareyama Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939443
- Sponsor's protocol ID
- NCH 14-3
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Inguinal Hernia by Prone- vs. Supine-position Computed Tomography
- ClinicalTrials.gov ID
- NCT02939443
- Acronym / sponsor ID
- NCH 14-3
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nagareyama Central HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair.
Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine and prone positions for preoperative assessment. The anatomy of the right and left inguinal regions was confirmed during the surgery and compared with the preoperative CT findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross-sectional study | Other | Radiation: supine- and prone-position Computed Tomography |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- inguinal hernia
Key exclusion criteria (3 listed)
- emergency surgery for incarcerated hernia
- femoral hernia
- recurrent inguinal hernia after laparoscopic inguinal hernia repair
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 |
|---|---|---|
| supine- and prone-position Computed Tomography | Radiation | cross-sectional study |
Primary outcome
The detection rate of inguinal hernia
Time frame: two years
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 20 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing supine- and prone-position Computed Tomography in people with Hernia, Inguinal, run by Nagareyama Central Hospital.
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 3 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The detection rate of inguinal hernia (time frame: two 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 20 Oct 2016.