Polypropylene Mesh in Prolapse Surgery | NCT02383199

Studies
Polypropylene Mesh in Prolapse Surgery

NCT02383199

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Mar 27, 2015Estimated

Enrollment

161Actual

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 2, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective outcome with validated questionnaires	Validated questionnaires	7 years

Secondary Outcomes

Measure	Description	Time Frame
Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system		7 years
Number of patients with adverse events and reoperations.	POP-Q	7 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

195 first patients with pelvic organ prolapse operated on using polypropylene mesh

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

195 first patients with pelvic organ prolapse operated on a in Turku University Hospital using polypropylene mesh

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pia Heinonen, MD	Turku university hospital, Department of gynecology and obsteterics, Turku, Finland':'	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided