Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- perineal wound complications
研究概览
简要总结
Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. A systematic review suggested a significant decrease in perineal wound complications when using incisional negative pressure wound therapy was demonstrated, with surgical site infection rates as low as 9% (vs 41% in control groups). The review suggested that incisional negative pressure wound therapy decreases perineal wound complications after abdominoperineal resection. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal cancer within 4 cm of the anal verge
- •T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy
- •Absence of distant metastases
- •Absence of intestinal obstruction
排除标准
- •T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy
- •Distant metastases
- •Intestinal obstruction
- •Pregnancy or lactating
- •Contraindications to surgery
- •A mental disorder
结局指标
主要结局
perineal wound complications
时间窗: 6 months after operation
perineal wound complications after pelvic floor reconstruction following ELAPE
次要结局
未报告次要终点
研究者
Zhen Jun Wang
Chairman of General Surgery
Beijing Chao Yang Hospital
