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Patient Centered Outcomes Study

Primary Purpose

Hernia, Ventral

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Disclosure timing

About this trial

This is an interventional other trial for Hernia, Ventral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.)

Sites / Locations

Lyndon B. Johnson General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Disclosure before

Disclosure after

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient Centered Outcomes (PCO)

Difference in PCO from initial survey to follow-up survey

Secondary Outcome Measures

Full Information

NCT ID

NCT04355819

First Posted

April 17, 2020

Last Updated

June 21, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04355819

Brief Title

Patient Centered Outcomes Study

Official Title

Patient Centered Outcomes Among Patients With and Without Ventral Hernia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 29, 2016 (Actual)

Primary Completion Date

October 3, 2018 (Actual)

Study Completion Date

October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Several questions exist when looking at ventral hernias: what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia? what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)? what is the natural history of quality of life of patients with and without a ventral hernia? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Ventral

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Disclosure before

Arm Type

Experimental

Arm Description

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

Arm Title

Disclosure after

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Disclosure timing

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient Centered Outcomes (PCO)

Description

Difference in PCO from initial survey to follow-up survey

Time Frame

Consent to 1 year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Holihan, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lyndon B. Johnson General Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77026

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Patient Centered Outcomes Study

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