Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial: The ProPro Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- postoperative adverse events
研究概览
简要总结
there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.
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
盲法说明
Compared progrip mesh with proflor mesh
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •bilateral inguinal hernia
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
结局指标
主要结局
postoperative adverse events
时间窗: 30-postoperative days
postoperative adverse events. The primary objective of these evaluations was to detect any possible complications that may have arisen, including but not limited to recurrence, hematoma, seroma, testicular swelling, wound infection/abscesses, prosthesis displacement, or any other complication. We used clinical observation and radiological findings to detect these complications.
次要结局
- Carolinas Comfort Scale (CCS)(1 - 6- 12 and 24 months)
- Visual analogue score (VAS)(1 - 6- 12 and 24 months)
研究者
Prof. Antonino Agrusa
Full Professor of Surgery
University of Palermo