Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups
研究概览
简要总结
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
详细描述
Inclusion and Exclusion Criteria
Inclusion criteria:
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Exclusion criteria
- Recurrent hernias
- Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
- Hypersensitivity to any drug in study
- Patients with an intra-operative findings of different pathology will be excluded from the study
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, adult patients
- •ASA I-III patients
- •Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- •Informed consent
排除标准
- •Recurrent hernias
- •Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
- •Hypersensitivity to any drug in study
- •Patients with an intra-operative findings of different pathology will be excluded from the study
研究组 & 干预措施
1
The Lichtenstein tension-free hernioplasty with polypropylene mesh
干预措施: Prolene Polypropylene Mesh (Device)
2
The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0.
干预措施: Surgisis Inguinal Hernia Matrix (Device)
结局指标
主要结局
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups
时间窗: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
次要结局
- to measure the recurrence rate(1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years)
- to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.(1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years)
- to rate the wound infection risk.(1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years)
- to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).(3, 6 months, 1, 2, 3, 4, 5 years)