NCT04355819

Brief Summary

Several questions exist when looking at ventral hernias:

  1. 1.what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia?
  2. 2.what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)?
  3. 3.what is the natural history of quality of life of patients with and without a ventral hernia?
  4. 4.what is the impact of disclosure of presence or absence of a ventral hernia on quality of life?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

April 17, 2020

Last Update Submit

June 21, 2023

Conditions

Hernia, Ventral

Outcome Measures

Primary Outcomes (1)

  • Patient Centered Outcomes (PCO)

    Difference in PCO from initial survey to follow-up survey

    Consent to 1 year follow-up

Study Arms (2)

Disclosure before

EXPERIMENTAL

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

Behavioral: Disclosure timing

Disclosure after

EXPERIMENTAL

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

Behavioral: Disclosure timing

Interventions

Disclosure timingBEHAVIORAL

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

Disclosure afterDisclosure before

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18 years or older
  • Patients at LBJ Hospital
  • Patients who received a CT of the abdomen

You may not qualify if:

  • Children (under age 18 years old)
  • Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Related Publications (1)

  • 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.

    PMID: 37369887DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Holihan, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

August 29, 2016

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)