Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Rate of surgical repair of the ventral hernias per patient year
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of surgical repair of the ventral hernias per patient year
时间窗: Once a year for 5 years
次要结局
- 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)
研究者
Mike K Liang
Assistant Professor
The University of Texas Health Science Center, Houston