Non-Op Management of Ventral Hernia Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | July 2015 |
| End Date: | June 2020 |
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.
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.
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
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