Alterations in Connective Tissue in Patients With or With... | NCT01749696

Studies
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse

NCT01749696

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

May 9, 2014Estimated

Enrollment

78Actual

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Not provided

Countries

Finland

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

May 2014

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

Nov 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Apr 2014Actual

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 17, 2012Estimated

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

May 8, 2014

Last Update Posted Date

May 9, 2014Estimated

Description Module

Brief Summary

The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).

Detailed Description

The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.

The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with pelvic organ prolapse		Patients, who were operated on because of pelvic organ prolapse.
Patients without pelvic organ prolapse		Patients, who had hysterectomy due to other reasons than pelvic organ prolapse.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The elastin content in tissue samples in patients with or without pelvic organ prolapse.		september 2012

Secondary Outcomes

Measure	Description	Time Frame
The collagen content in tissue samples in women with or without pelvic organ prolapse.		September 2012

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgery for pelvic organ prolapse
hysterectomy due to other benign reasons than pelvic organ prolapse

Exclusion Criteria:

surgery due to malignancy

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

39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Turku University Central Hospital		Turku		20520	Finland

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D021921	Aortic Stenosis, Supravalvular

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D001024	Aortic Valve Stenosis

Browse Leaves

Not provided

Browse Branches

Not provided