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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04355819
Other study ID # HSC-MS-16-0698
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 29, 2016
Est. completion date October 3, 2018

Study information

Verified date June 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date October 3, 2018
Est. primary completion date October 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Disclosure timing
When patients are told that a hernia was present on the CT scan

Locations

Country Name City State
United States Lyndon B. Johnson General Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Centered Outcomes (PCO) Difference in PCO from initial survey to follow-up survey Consent to 1 year follow-up
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