Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- intra-operative complications
研究概览
简要总结
Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.
详细描述
Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse
排除标准
- •other condition than rectal prolapse
研究组 & 干预措施
Rectal Prolapse
Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.
干预措施: Laparoscopic ventral mesh rectopexy (Procedure)
结局指标
主要结局
intra-operative complications
时间窗: 30 days postoperative
All complications occur during the operation and discovered and managed during the operation or passed undiscovered and discovered postoperative during the same admission or require readmission
次要结局
未报告次要终点
研究者
Pierpaolo Sileri
Prof
University of Rome Tor Vergata