Patient Centered Outcomes Study

Overview

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.

Full Title of Study: “Patient Centered Outcomes Among Patients With and Without Ventral Hernia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 3, 2018

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Patient Centered Outcomes (PCO)
    • Time Frame: Consent to 1 year follow-up
    • Difference in PCO from initial survey to follow-up survey

Participating in This Clinical Trial

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.)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Holihan, Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Julie Holihan, MD, Principal Investigator, The University of Texas Health Science Center, Houston

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