Hernia, Ventral
Conditions
Keywords
non-operative management
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.
Interventions
None listed
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of surgical repair of the ventral hernias per patient year | Once a year for 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of emergency repair of ventral hernias per patient year | Once a year for 5 years |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Change in pain from baseline using the Visual Analog Scale for Pain | Once a year for 5 years |
| Change in patient function from baseline using the HerQLes Survey | Once a year for 5 years |
| Change in patient quality of life from baseline using the HerQLes Survey | Once a year for 5 years |
| Change in hernia size based on clinical exam or CT scan | Once a year for 5 years |
Countries
United States
Outcome results
None listed