The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- early postoperative complications
研究概览
简要总结
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia.
排除标准
- •Recurrent inguinal hernia
- •Incarcerated inguinal hernia
- •Hernia not in the inguinal area
- •Signs of obvious local or systemic infection
- •ASA score > 4
- •Presenting with unstable angina or NYHA class of IV
- •Active drug user
- •Immunosuppression, chemotherapy
- •Chronic renal insufficiency
- •Abdominal ascites
- •Infection in area of the surgical field
研究组 & 干预措施
ProFlor
patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold
干预措施: inguinal hernia repair with mesh (Procedure)
Lichtenstein
patients underwent to Lichtenstein inguinal hernia repair
干预措施: inguinal hernia repair with mesh (Procedure)
结局指标
主要结局
early postoperative complications
时间窗: 30 days after surgery
bleeding, hematoma and infections
patients clinical outcome
时间窗: 24 months
VAS score
次要结局
- evaluation of quality of life during the postoperative period(24 months)
研究者
Prof. Antonino Agrusa
full professor of surgery
University of Palermo