NCT01183325已完成不适用
Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Percentage of adequately placed patches
研究概览
简要总结
For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.
About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).
With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.
The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patient
- •Written informed consent
- •Umbilical, primary ventral hernias smaller than 3cm diameter
排除标准
- •Hernias larger than 3cm
- •Recurrence
- •Emergency cases
- •Incisional hernias
结局指标
主要结局
Percentage of adequately placed patches
时间窗: At T 0 days
次要结局
- Reasons for inadequate positioning(At T 0 days)
- Perioperative morbidity rate(Within 30 days)
- Number of patients needed a repositioning of the patch(At T 0 days)
- Number of repositioning necessary(At T 0 days)
- Complication ratio(At 1 year)
- Pre- and postoperative pain(At T 0 day, T 30 days and T 1 year)
- Recurrence rate at 1 year(At 1 year)
研究者
研究点 (3)
Loading locations...
相似试验
终止
不适用
Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral HerniasVentral HerniaEpigastric HerniaUmbilical HerniaNCT01639118Algemeen Ziekenhuis Maria Middelares11
尚未招募
不适用
Minimally Invasive Techniques in Ventral HernioplastyVentral HerniaNCT06255314Assiut University45
已完成
不适用
Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral HerniasVentral HerniaEpigastric HerniaUmbilical HerniaNCT04150796The Cleveland Clinic100
Unknown
不适用
Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-PatchVentral HerniaEpigastric HerniaTrocar-site HerniaUmbilical HerniaNCT01761708Algemeen Ziekenhuis Maria Middelares57
已完成
不适用
A Multicenter Belgian Trial of Ventral Hernia Repair (UNITE)Ventral HerniaNCT04437043University Hospital, Ghent100