Patient Centered Outcomes Study
Overview
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. 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.
Full Title of Study: “Patient Centered Outcomes Among Patients With and Without Ventral Hernia”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Single (Participant)
- Study Primary Completion Date: October 3, 2018
Interventions
- Behavioral: Disclosure timing
- When patients are told that a hernia was present on the CT scan
Arms, Groups and Cohorts
- Experimental: Disclosure before
- Patients will be told that a hernia was found on CT before the follow-up survey is administered.
- Experimental: Disclosure after
- Patients will be told that a hernia was found on CT after the follow-up survey was administered.
Clinical Trial Outcome Measures
Primary Measures
- Patient Centered Outcomes (PCO)
- Time Frame: Consent to 1 year follow-up
- Difference in PCO from initial survey to follow-up survey
Participating in This Clinical Trial
Inclusion Criteria
- Adults age 18 years or older – Patients at LBJ Hospital – Patients who received a CT of the abdomen Exclusion Criteria:
- Children (under age 18 years old) – Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- The University of Texas Health Science Center, Houston
- Provider of Information About this Clinical Study
- Principal Investigator: Julie Holihan, Assistant Professor – The University of Texas Health Science Center, Houston
- Overall Official(s)
- Julie Holihan, MD, Principal Investigator, The University of Texas Health Science Center, Houston
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