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临床试验/NCT04033484
NCT04033484Unknown不适用

Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision

Beijing Chao Yang Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年7月1日最近更新:
适应症

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

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

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Jun Wang

Chairman of General Surgery

Beijing Chao Yang Hospital

研究点 (2)

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