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

NCT ID: NCT02465710

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

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.

Conditions

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Pelvic Organ Prolapse

Keywords

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pelvic organ prolapse pelvic floor reconstruction surgery transvaginal mesh surgery Women Surgical treatment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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pelvic organ prolapse

All women who underwent surgical treatment of pelvic organ prolapse in this study.

Pelvic organ prolapse surgery without mesh

Intervention Type PROCEDURE

retrospective study

Pelvic organ prolapse surgery with mesh

Intervention Type PROCEDURE

Interventions

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Pelvic organ prolapse surgery without mesh

retrospective study

Intervention Type PROCEDURE

Pelvic organ prolapse surgery with mesh

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ho-Hsiung Lin, MD,PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Sheng-Mou Hsiao

Role: CONTACT

Phone: 886-2-89667000

Email: [email protected]

Facility Contacts

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Ho-Hsiung Lin, MD, PhD

Role: primary

Sheng-Mou Hsiao

Role: backup

Other Identifiers

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201504023RINC

Identifier Type: -

Identifier Source: org_study_id