Non-Op Management of Ventral Hernia Patients

• Conditions: Hernia, Ventral

• Registration Number: NCT02457364
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Study Start: 2015-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of surgical repair of the ventral hernias per patient year	Once a year for 5 years

Secondary Outcome Measures

Name	Time	Method
Rate of elective repair of ventral hernias per patient year	Once a year for 5 years
Rate of emergency room visits per patient year	Once a year for 5 years
Rate of emergency repair of ventral hernias per patient year	Once a year for 5 years

Trial Locations

Locations (1)

LBJ General Hospital-UT Health; 🇺🇸 Houston, Texas, United States