Patient Centered Outcomes Study

NCT ID: NCT04355819

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-29

Study Completion Date

2018-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia, Ventral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Disclosure before

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

Group Type EXPERIMENTAL

Disclosure timing

Intervention Type BEHAVIORAL

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

Disclosure after

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

Group Type EXPERIMENTAL

Disclosure timing

Intervention Type BEHAVIORAL

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

Interventions

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Disclosure timing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Julie Holihan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Holihan, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Lyndon B. Johnson General Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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Olavarria OA, Lyons NB, Bernardi K, Dhanani NH, Neela N, Arakelians A, Cohen BL, Mohebzad K, Coelho R, Holihan JL, Liang MK. Impact of disclosure of radiographic test results on quality of life among patients with hernias: a randomized controlled trial. Hernia. 2024 Apr;28(2):411-418. doi: 10.1007/s10029-023-02824-w. Epub 2023 Jun 27.

Reference Type DERIVED
PMID: 37369887 (View on PubMed)

Other Identifiers

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HSC-MS-16-0698

Identifier Type: -

Identifier Source: org_study_id

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