Clinical trial NCT02457364: Non-Op Management of Ventral Hernia Patients
Official title: Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hernia, Ventral
Keywords: non-operative management
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of surgical repair of the ventral hernias per patient year
timeFrame: Once a year for 5 years
Secondary outcomes:
measure: Rate of emergency repair of ventral hernias per patient year
timeFrame: Once a year for 5 years
measure: Rate of elective repair of ventral hernias per patient year
timeFrame: Once a year for 5 years
measure: Rate of emergency room visits per patient year
timeFrame: Once a year for 5 years
Other outcomes:
measure: Change in pain from baseline using the Visual Analog Scale for Pain
timeFrame: Once a year for 5 years
measure: Change in patient function from baseline using the HerQLes Survey
timeFrame: Once a year for 5 years
measure: Change in patient quality of life from baseline using the HerQLes Survey
timeFrame: Once a year for 5 years
measure: Change in hernia size based on clinical exam or CT scan
timeFrame: Once a year for 5 years
Locations:
city: Houston
country: United States
facility: LBJ General Hospital-UT Health
state: Texas
Study officials:
References:
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