Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse

Study Overview
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Brief Summary
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The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics & Gynecology of National Taiwan University Hospital.

Detailed Description
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Hypothesis / aims of study: The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP. Study design, materials and methods: Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.

Official Title
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Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Pelvic organ prolapse surgery without mesh
* Procedure: Pelvic organ prolapse surgery with mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study. ≥ 20 years old female. Exclusion Criteria: Healthy women Without underwent surgical treatment of pelvic organ prolapse

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pelvic organ prolapse<br>All women who underwent surgical treatment of pelvic organ prolapse in this study. | Procedure: Pelvic organ prolapse surgery without mesh<br>* retrospective study<br>Procedure: Pelvic organ prolapse surgery with mesh<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of pelvic organ prolapse | follow-up till postoperative 5 years | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, pelvic floor reconstruction surgery, transvaginal mesh surgery, Women, Surgical treatment