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Patient Centered Outcomes Study

NCT04355819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-06-23

No results posted yet for this study

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.

Conditions

  • Hernia, Ventral

Interventions

BEHAVIORAL

Disclosure timing

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Julie Holihan, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2018-10-03
Completion
2018-10-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355819 on ClinicalTrials.gov