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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00564044 |
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Date of registration:
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25/11/2007 |
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Primary sponsor: |
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Public title:
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The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.
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Scientific title:
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Does the Immune Reactivity of Bacteria Cause Vaginal Mesh (Polypropylene) Erosion? - A Ultrastructural, Microbiological and Immunohistochemical Analysis. |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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82 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00564044 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Min-Chi Chen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biostatistics Center and Department of Public Health, Chang Gung University |
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Name:
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Cheng-Hsun Chiu, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics, Chang Gung Memorial Hospital |
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Name:
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Ren-Chin Wu, MD |
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Address:
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Email:
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Affiliation:
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Department of Surgical Pathology, Chang Gung Memorial Hospital |
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Name:
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Alex Wang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital |
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Name:
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Tsia-Shu Lo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital |
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Name:
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Yi-Haou Lin, MD |
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Address:
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Email:
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Affiliation:
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Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Chang Gung Memorial Hospital |
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Name:
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Cheng-Tao Lin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gynecological Oncology, Department of OB/GYN, Chang Gung Memorial Hospital |
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Name:
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Yu-Shien Ko, MD, PhD |
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Address:
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Email:
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Affiliation:
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First Cardiovascular Division, Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fecal Incontinence
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Urinary Incontinence
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Uterine Prolapse
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Intervention(s)
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Procedure: excision of the protruding mesh and its surrounding vaginal tissue
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Primary Outcome(s)
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To determine whether bacterial infection with biofilm formation exists in the vaginal tissue with mesh extrusion using bacterial culture and electron microscopic analysis.
[Time Frame: 3 years]
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Secondary Outcome(s)
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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.
[Time Frame: 3 years]
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Secondary ID(s)
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NMRPD160851
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NSC96-2314-B-182-015-MY1
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NSC96-2314-B-182-015-MY2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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