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OpenTrials
Completed

NCT Number: NCT04355819

Patient Centered Outcomes Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Disclosure timing

Behavioral

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

Primary outcomes

  1. Patient Centered Outcomes (PCO)

    Time frame: Consent to 1 year follow-up

    Difference in PCO from initial survey to follow-up survey

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Patient Centered Outcomes Among Patients With and Without Ventral Hernia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2020
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.