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NCT02383199 Clinical Trial

Polypropylene Mesh in Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

Official title:
Polypropylene Mesh in Prolapse Surgery; Long-term Outcome and Complications.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02383199
Other study ID # 134/2013
Secondary ID
Status Completed
Phase N/A
First received February 2, 2015
Last updated March 26, 2015
Start date September 2013
Est. completion date November 2014

Study information
Verified date March 2015
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date November 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 195 first patients with pelvic organ prolapse operated on using polypropylene mesh

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective outcome with validated questionnaires Validated questionnaires 7 years No
Secondary Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system 7 years No
Secondary Number of patients with adverse events and reoperations. POP-Q 7 years No
See also
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
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Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A
Completed NCT00551993 - Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse N/A