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临床试验/NCT00564044
NCT00564044Unknown不适用

Does the Immune Reactivity of Bacteria Cause Vaginal Mesh (Polypropylene) Erosion? - A Ultrastructural, Microbiological and Immunohistochemical Analysis.

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2007年8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
82
试验地点
2
主要终点
To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.

研究概览

简要总结

Aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced pelvic organ prolaspe, fecal as well as urinary incontinence. Surgical treatment is the last resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except the subject is too frail to receive operation.

In order to improve the outcome of reconstructive pelvic surgery, reinforcement with synthetic mesh or biological material is the modern trend in pelvic repair. Unfortunately no prosthesis including synthetic or biological is ideal because vaginal erosion with mesh extrusion which is the subject of this protocol and other complications were reported continuously. As per the literature, the rate for mesh vaginal extrusion ranged between 2.4 and 17% when polypropylene which is the most popular synthetic material used for the mid-urethral sling or pelvic reconstructive surgery to date. The causes of this complication are still controversial which include rejection, poor quality of tissue, surgical artifact, material of mesh and etc.

A prospective controlled study for the investigation of the cause for mesh vaginal erosion was conducted and the results revealed evidences of immune reactivity after mesh implantation, albeit the evidence was not solid (Am J Obstet Gynecol 2004; 191(6): 1868-1874 ). As per the pilot study initially done by us to determine the biofilm-related-infection, we have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located in the cells just beneath the contacting surfaces in the electron microscopic (EM) analysis. In addition, soon after bacteria infection, proteins in biofilm undergo conformational changes, making them immunogenic and triggers a typical inflammatory response leading to activation of the complement system. Thus, we plan to use CD (clusters of differentiation) antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of FoxP3 to determine the function of regulatory T cells in the immune response. In addition, bacterial culture and EM analysis of the excised mesh with surrounding vagina tissue will be performed for further analysis of biofilms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Study arm: Subjects present with mesh erosion in vaginal after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.
  • Control arm: Subjects present with symptomatic vaginal prolapse but without mesh erosion after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.

排除标准

  • Study arm: The eligible subjects with fasting sugar level ≥ 180mg/dL, post prandial sugar level ≥ 230mg/dL.
  • Control arm: Polypropylene mesh placement less than 6 months.

结局指标

主要结局

To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.

时间窗: 3 years

次要结局

  • With the use of immunohistochemical (IHC) analysis of CD 4, 8, 20, 25, 40, 68 and quantitative analysis of Fox P3 (using RT-POR), to determine the function of regulatory T cells in the immune reactivity of biofilms.(3 years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other

研究点 (2)

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