NCT00749268已完成4 期
Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
- •Age > 18 years
- •Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use
排除标准
- •Pregnancy
- •Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
- •Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
- •History of alcohol or drug abuse within 6 months prior to screening
- •History of chronic pain condition requiring more than 30 days of medical management
- •Use of an additional nonresorbable means of fixation (inguinal)
- •Patients considered not able to comply with the protocol and follow up schedule
- •ASA grade of 4 or above
研究组 & 干预措施
A
Active Comparator
干预措施: AbsorbaTack (Device)
B
Active Comparator
干预措施: ProTack (Device)
结局指标
主要结局
Postoperative Pain
时间窗: Discharge, Month 1, Month 6, Month 12
Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events
时间窗: One year
次要结局
- Hernia Recurrence(Discharge, 1 Month, 6 Month, 1 year)
- Quality of Life(Pre-op, Month 1, Month 6, 1 year)
研究者
研究点 (2)
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