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临床试验/NCT06166069
NCT06166069已完成不适用

Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study

Azienda Sanitaria Locale Napoli 2 Nord1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
1
主要终点
Number of patients affected by Deep surgical site infections

研究概览

简要总结

Background: Ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk.

Objective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair.

Methods: Retrospective analysis of patients undergoing surgery in eight Italian Surgery Centers, evaluating pIPOM and sIPOM techniques with GORE® SYNECOR IP Biomaterial. Preoperative evaluations included anthropometric measurements, comorbidities, CT scans, and GIQLI assessments. Surgical procedures and interventions were recorded. Postoperative complications, GIQLI changes, cosmesis, hernia recurrence, and mesh bulging were assessed.

详细描述

The management of ventral hernias, whether they are primary or incisional, presents a significant challenge for abdominal wall surgeons. Laparoscopic ventral hernia repair has become a widely accepted technique on a global scale, with literature reporting favorable outcomes, even over the long term. Nevertheless, various substantial controversies have emerged concerning the ideal approach and patient selection and "ideal mesh". Permanent mesh materials with a macro-porous structure have demonstrated excellent durability, a low risk of infection in ventral hernia repair. Nevertheless, hernia recurrences and complications can still occur. The use of absorbable mesh materials may reduce the risk of infectious complications and the need for mesh removal. However, it might be associated with a higher likelihood of long-term recurrence when compared to permanent materials.

In response to these challenges, hybrid mesh materials, combining both absorbable and permanent components, have been developed to strike a balance between achieving long-term durability and minimizing the risk of infection or "Mesh removal". These hybrid meshes can be utilized either intraperitoneally or extra-peritoneally depending on their composition.

One example of such a hybrid mesh is the GORE® SYNECOR Intraperitoneal Biomaterial (referred to as the device), manufactured by W.L. Gore & Associates, Inc. in Flagstaff, AZ. This composite mesh comprises a bioabsorbable 3D web scaffold and a permanent dense polytetrafluoroethylene (PTFE) monofilament macro-porous knit. The device is specifically designed for intraperitoneal placement, using either an underlay or intraperitoneal onlay technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • Clean wounds
  • Informed consent
  • Patients affected by Incisional and Ventral Hernia
  • Elective surgery
  • Hernia size between 3 e 10 cm

排除标准

  • age < 18 years;
  • Life expectancy < 24 months (as estimated by the operating surgeon), -
  • Pregnancy
  • Immunosuppressant therapy within 2 weeks before surgery
  • Clean-contaminated and contaminated, dirty wounds
  • Cirrhosis

结局指标

主要结局

Number of patients affected by Deep surgical site infections

时间窗: Within 30 days postoperatively

Deep surgical site infections according to Clavien-Dindo criteria

Number of patients affected by organ space infections

时间窗: Within 30 days postoperatively

Organ space infections according to Clavien-Dindo criteria

Number of patients affected by Surgical Site Occurence

时间窗: Within 30 days postoperatively

Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions

Postoperative pain

时间窗: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.

Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Number of patients affected by Superficial surgical site infections

时间窗: Within 30 days postoperatively

Superficial infections according to Clavien-Dindo criteria

次要结局

  • Rate of Incisional Hernia at Clinical examination(Patients are postoperatively examined at 12 months.)
  • Rate of Incisional Hernia at ultrasonographic examination(Patients are postoperatively examined at 12 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pizza

PhD, Md

Azienda Sanitaria Locale Napoli 2 Nord

研究点 (1)

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