NCT03091790已完成不适用
Mesh Type in Ventral Hernia Repair
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年3月27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
- 87
- 试验地点
- 2
- 主要终点
- Complication free at 1 year post-operative
研究概览
简要总结
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.
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, Outcomes Assessor)
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 scheduled for open ventral hernia repair at LBJ General Hospital
排除标准
- •Active infection
- •Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
- •Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
- •Patient unlikely to follow-up (i.e. no phone)
结局指标
主要结局
Complication free at 1 year post-operative
时间窗: 1 year after surgery
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
次要结局
- Dindo-clavien complications(Pre-operative, 1 month after surgery, 1 year and 3 years after surgery)
- Complication free at 3 years post-operative(3 years after surgery)
- Cost(1 year and 3 years after surgery)
- Patient centered outcomes(Pre-operative, 1 month after surgery, 1 year and 3 years after surgery)
研究者
Julie Holihan
Staff Physician
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Biological Mesh Repair of Complex Hernias in High Risk PatientsHerniaNCT01997619Rigshospitalet, Denmark16
已完成
不适用
Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian StudyLaparoscopicIncisional HerniaHerniaNCT06166069Azienda Sanitaria Locale Napoli 2 Nord272
已完成
不适用
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.Primary and Secondary Ventral HerniaNCT01622725University Hospital, Ghent95
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
Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh RepairHernia, VentralNCT00532870Mansoura University