Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000007932
Ethics application status
Approved
Date submitted
17/12/2010
Date registered
4/01/2011
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Description of the perineal body in women presenting with a posterior vaginal compartment prolapse, clinical presentation and outcome of the surgical management
Scientific title
An observational study to evaluate and to define the different types of perineal body presentations before and after prolapse surgery in women with a posterior vaginal compartment prolapse
Secondary ID [1] 253303 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
posterior vaginal compartment prolapse 258835 0
Condition category
Condition code
Surgery 258973 258973 0 0
Surgical techniques
Renal and Urogenital 259012 259012 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
observational study
description of the perineal body in women unergoing prolapse surgery for the condition of a posterior vaginal compartment prolapse. Patients will be followed up 6 weeks and 3 months postoperatively.
Intervention code [1] 257751 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259828 0
description of the perineal body in women undergoing surgery for the condition of a posterior vaginal comparment prolapse.
Women will be examined intraoperatively and postoperatively according to the ICS POP-Q system. The Queensland Pelvic Floor Questionnaire will be completed as any patients undergoing prolapse surgery pre- and postoperatively.
Timepoint [1] 259828 0
intraoperatively
immediately postoperatively
6 weeks postoperatively
Secondary outcome [1] 268659 0
Outcome of the surgical intervention.
Women will be examined intraoperatively and postoperatively according to the ICS POP-Q system. The Queensland Pelvic Floor Questionnaire will be completed as any patients undergoing prolapse surgery pre- and postoperatively.
Timepoint [1] 268659 0
6 weeks postoperatively

Eligibility
Key inclusion criteria
women undergoing vaginal prolapse surgery for the condition of a posterior vaginal compartment prolapse
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258220 0
Self funded/Unfunded
Name [1] 258220 0
Country [1] 258220 0
Australia
Primary sponsor type
Individual
Name
Dr. Corina Schmid
Address
Department for Urogynaecology RBWH
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 257388 0
None
Name [1] 257388 0
Address [1] 257388 0
Country [1] 257388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260203 0
Institutional Review Board (IRB) for Low and Negligible Risk Research, RBWH
Ethics committee address [1] 260203 0
Royal Brisbane and Womens Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 260203 0
Australia
Date submitted for ethics approval [1] 260203 0
Approval date [1] 260203 0
22/11/2010
Ethics approval number [1] 260203 0

Summary
Brief summary
We aim to define the different types of perineal body presentations in women with posterior vaginal compartment prolapse, to determine the incidence of this condition and to assess the outcome of our intervention.
This observatorial study is conducted to obtain a better understanding of the pathophysiology of the posterior vaginal compartment with the focus on the perineum.
The hypothesis is to identify the different perineal defects in women undergoing posterior vaginal compartment prolapse which have not clearly described and defined in current literatur. The accurately description of perineal defects will improve the surgical management of this common condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32020 0
Address 32020 0
Country 32020 0
Phone 32020 0
Fax 32020 0
Email 32020 0
Contact person for public queries
Name 15267 0
Corina Schmid
Address 15267 0
RBWH Department for Urogynaecology
Butterfield Street
Herston
QLD 4029
Country 15267 0
Australia
Phone 15267 0
+61 (0)44 9822896
Fax 15267 0
Email 15267 0
[email protected]
Contact person for scientific queries
Name 6195 0
Corina Schmid
Address 6195 0
RBWH Department for Urogynaecology
Butterfield Street
Herston
QLD 4029
Country 6195 0
Australia
Phone 6195 0
+61 (0)44 9822896
Fax 6195 0
Email 6195 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Prospective Observational Study of the Classification of the Perineum and Evaluation of Perineal Repair at the Time of Posterior Colporrhaphy.2016https://dx.doi.org/10.1097/SPV.0000000000000314
N.B. These documents automatically identified may not have been verified by the study sponsor.