Patient Centered Outcomes Study

The University of Texas System (UT)

Status: Completed

Conditions: Hernia, Ventral

Treatments: Behavioral: Disclosure timing

Study type: Interventional

Funder types: Other

Identifiers

NCT04355819

HSC-MS-16-0698

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Disclosure before

Experimental group

Description:

Patients will be told that a hernia was found on CT before the follow-up survey is administered.

Treatment:

Behavioral: Disclosure timing

Disclosure after

Experimental group

Description:

Patients will be told that a hernia was found on CT after the follow-up survey was administered.

Treatment:

Behavioral: Disclosure timing