Non-Op Management of Ventral Hernia Patients

April 30, 2018 updated by: Mike K Liang, The University of Texas Health Science Center, Houston

Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair

Ventral hernias are among the most common surgical diseases among patients.The natural history of patients with ventral hernias who are managed non-operatively is unknown. The aim of this prospective trial is to document the natural history of patients who are undergoing initially non-operative management. The investigators hypothesize that 1) the risk of emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is high, and 3) patients managed non-operatively will develop increasing hernia size and symptom progression. This is a prospective observational study of all patients undergoing non-operative management at LBJ General Hospital. Patients will be consented and then followed for 5 years. Phone interviews will be done with these patients yearly to assess surgical and medical history, information about their hernia, including pain level due to the hernia, as well as function and quality of life.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77026
        • LBJ General Hospital-UT Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.

Description

Inclusion Criteria:

  • All patients undergoing initial non-operative management as chosen by current practice patterns
  • All patients who opt for non-operative management due to personal choice, lack of symptoms or concerns regarding surgical risks.
  • Age 18 or older

Exclusion Criteria:

  • Patient meets surgery criteria but elects for surgery within 1 year due to personal scheduling
  • Patient smokes < 1 pack per day, is actively quitting smoking, and desires to follow-up within 3 months upon smoking cessation
  • Patient with BMI < 35 kg/m2, is actively losing weight, and desires to follow-up within 3 months upon weight loss goals being met
  • Patient is unlikely to be able to follow-up due to no personal or home phone
  • Patient is enrolled in another trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of surgical repair of the ventral hernias per patient year
Time Frame: Once a year for 5 years
Once a year for 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of emergency repair of ventral hernias per patient year
Time Frame: Once a year for 5 years
Once a year for 5 years
Rate of elective repair of ventral hernias per patient year
Time Frame: Once a year for 5 years
Once a year for 5 years
Rate of emergency room visits per patient year
Time Frame: Once a year for 5 years
Once a year for 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Change in pain from baseline using the Visual Analog Scale for Pain
Time Frame: Once a year for 5 years
Once a year for 5 years
Change in patient function from baseline using the HerQLes Survey
Time Frame: Once a year for 5 years
Once a year for 5 years
Change in patient quality of life from baseline using the HerQLes Survey
Time Frame: Once a year for 5 years
Once a year for 5 years
Change in hernia size based on clinical exam or CT scan
Time Frame: Once a year for 5 years
Once a year for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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