NCT01073072已完成3 期
Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
Centre Hospitalier Régional Universitaire Montpellier35 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 35
- 主要终点
- risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
研究概览
简要总结
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.
The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.
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
- Single (Participant)
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
- •Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:
- •Infected incisional hernia: abdominal wall abscess, chronic fistula
- •Incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin)
- •Recurrent incisional hernia with problem of cutaneous healing
- •Incisional hernia requiring important intestinal adhesiolysis
- •Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old
排除标准
- •Patient with major anesthetic risk (ASA 4)
- •Patient suffering from immunodepression or under immunosuppressor treatment (corticoids...)
- •Patients already enrolled in another study
- •Patient suffering from severe disease not allowing a 1-year follow-up
- •Patient refusing to be enrolled after consulting the information letter
- •Patient presenting with a too large incisional hernia, superior to 140x200 mm
- •Pregnancy
结局指标
主要结局
risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
时间窗: 30 days
次要结局
- recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report(1 year)
- the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics(1 year)
- the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.(1 year)
- the impact on patients' quality of life: The evaluation of patient's quality of life will be done with the questionnaire quality of life SF12(1 year)
研究者
David Nocca
Dr. David NOCCA, CHRU Montpellier
Centre Hospitalier Régional Universitaire Montpellier
研究点 (35)
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