Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2016-08-29
2018-10-03
Brief Summary
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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. what is the natural history of quality of life of patients with and without a ventral hernia?
4. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Disclosure before
Patients will be told that a hernia was found on CT before the follow-up survey is administered.
Disclosure timing
When patients are told that a hernia was present on the CT scan
Disclosure after
Patients will be told that a hernia was found on CT after the follow-up survey was administered.
Disclosure timing
When patients are told that a hernia was present on the CT scan
Interventions
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Disclosure timing
When patients are told that a hernia was present on the CT scan
Eligibility Criteria
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Inclusion Criteria
* Patients at LBJ Hospital
* Patients who received a CT of the abdomen
Exclusion Criteria
* Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)
18 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Julie Holihan
Assistant Professor
Principal Investigators
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Julie Holihan, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Lyndon B. Johnson General Hospital
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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HSC-MS-16-0698
Identifier Type: -
Identifier Source: org_study_id
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