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Patient Centered Outcomes Study

Patient Centered Outcomes Among Patients With and Without Ventral Hernia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04355819
Enrollment
500
Registered
2020-04-21
Start date
2016-08-29
Completion date
2018-10-03
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral

Brief 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. 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.

Interventions

BEHAVIORALDisclosure timing

When patients are told that a hernia was present on the CT scan

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Patient Centered Outcomes (PCO)Consent to 1 year follow-upDifference in PCO from initial survey to follow-up survey

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026