Hernia, VentralNCT04355819
Patient Centered Outcomes Study
A study testing Disclosure timing in people with Hernia, Ventral, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Several questions exist when looking at ventral hernias: 1. what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia? 2. what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)? 3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Disclosure timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2016to 3 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older
- Patients at LBJ Hospital
- Patients who received a CT of the abdomen
Who cannot join
- Children (under age 18 years old)
- Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
Official title: Patient Centered Outcomes Among Patients With and Without Ventral Hernia
Several questions exist when looking at ventral hernias:
- what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia?
- what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)?
- what is the natural history of quality of life of patients with and without a ventral hernia?
- what is the impact of disclosure of presence or absence of a ventral hernia on quality of life?
Answering these questions can provide valuable information on the impact of surgery with or without subsequent ventral hernia on a patient's abdominal wall function and quality of life.
- Conditions
- Hernia, Ventral
- Being tested
- Disclosure timing
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure timingBehavioural
When patients are told that a hernia was present on the CT scan
| Study group | Role | What they receive |
|---|---|---|
| Disclosure before | Experimental | Patients will be told that a hernia was found on CT before the follow-up survey is administered. Receives: Behavioral: Disclosure timing |
| Disclosure after | Experimental | Patients will be told that a hernia was found on CT after the follow-up survey was administered. Receives: Behavioral: Disclosure timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Centered Outcomes (PCO)
Difference in PCO from initial survey to follow-up survey
Measured: Consent to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start29 Aug 2016
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
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 Hernia, VentralStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Holihan, The University of Texas Health Science Center, Houston
- Investigators
- Julie Holihan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355819
- Sponsor's protocol ID
- HSC-MS-16-0698
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olavarria OA, Lyons NB, Bernardi K, Dhanani NH, Neela N, Arakelians A, Cohen BL, Mohebzad K, Coelho R, Holihan JL, Liang MK. Impact of disclosure of radiographic test results on quality of life among patients with hernias: a randomized controlled trial. Hernia. 2024 Apr;28(2):411-418. doi: 10.1007/s10029-023-02824-w. Epub 2023 Jun 27.
PubMed 37369887
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Outcomes Among Patients With and Without Ventral Hernia
- ClinicalTrials.gov ID
- NCT04355819
- Acronym / sponsor ID
- HSC-MS-16-0698
- Conditions
- Hernia, Ventral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 21 Apr 2020 (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.
Several questions exist when looking at ventral hernias:
- what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia?
- what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)?
- what is the natural history of quality of life of patients with and without a ventral hernia?
- what is the impact of disclosure of presence or absence of a ventral hernia on quality of life?
Answering these questions can provide valuable information on the impact of surgery with or without subsequent ventral hernia on a patient's abdominal wall function and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disclosure before | Experimental | Behavioral: Disclosure timingPatients will be told that a hernia was found on CT before the follow-up survey is administered. |
| Disclosure after | Experimental | Behavioral: Disclosure timingPatients will be told that a hernia was found on CT after the follow-up survey was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 years or older
- Patients at LBJ Hospital
- Patients who received a CT of the abdomen
Key exclusion criteria (2 listed)
- Children (under age 18 years old)
- Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)
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 |
|---|---|---|
| Disclosure timingWhen patients are told that a hernia was present on the CT scan | Behavioural | Disclosure after, Disclosure before |
Primary outcome
Patient Centered Outcomes (PCO)
Time frame: Consent to 1 year follow-up
Difference in PCO from initial survey to follow-up survey
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 23 Jun 2023.
- Derived from this study: PubMed 37369887Olavarria OA, Lyons NB, Bernardi K, Dhanani NH, Neela N, Arakelians A, Cohen BL, Mohebzad K, Coelho R, Holihan JL, Liang MK. Impact of disclosure of radiographic test results on quality of life among patients with hernias: a randomized controlled trial. Hernia. 2024 Apr;28(2):411-418. doi: 10.1007/s10029-023-02824-w. Epub 2023 Jun 27.
- Individual participant dataSharing planned: No
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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.
Julie Holihan, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure timing in people with Hernia, Ventral, 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?
The sponsor lists 3 inclusion and 2 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 23 Jun 2023. 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?
Patient Centered Outcomes (PCO) (time frame: Consent to 1 year follow-up). 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 NCT04355819, 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 23 Jun 2023.