A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 944
- 试验地点
- 17
- 主要终点
- Number of patient reported complications post 30-days through 3 years post procedure
研究概览
简要总结
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.
The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.
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
- •Age 18 years and older
- •All patients undergoing either an open, laparoscopic or robotic-assisted
- •Incisional or Inguinal Hernia repair procedure
- •Non-Emergent Incisional or Inguinal Hernia Repair cases
排除标准
- •Emergent Cases for both Incisional and Inguinal Hernia
- •Incisional Hernia related to ostomy formation
- •Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
结局指标
主要结局
Number of patient reported complications post 30-days through 3 years post procedure
时间窗: 30 days post-procedure to 3 years post-procedure
Number of long-term complications related to hernia repair directly reported by patients
Number of complications observed intraoperatively through 30 days
时间窗: 30 days
Number of intraoperative and short-term complications related to hernia repair.
次要结局
- Incisional or Inguinal Hernia Recurrence through 3 years(30 days post-procedure through 3 years)
- Patient reported outcomes on post-procedure pain through 3 years(2-4 weeks post-procedure through 3 years post-procedure)
- Patient reported outcomes on Quality of Life through 1 year(Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life)