Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000014954
Ethics application status
Approved
Date submitted
17/12/2010
Date registered
6/01/2011
Date last updated
6/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vaginal invagination:defintion, clinical presentation and surgical management
Scientific title
An observational study to describe the condition of a vaginal invagination and to assess the surgical outcome after releasing the vaginal invagination in women undergoing vaginal prolapse surgery.
Secondary ID [1] 253312 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the presentation of vaginal invagination intraoperatively and postoperatively. 258847 0
Condition category
Condition code
Surgery 258989 258989 0 0
Other surgery
Renal and Urogenital 259011 259011 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
This is a observational study. The condition of a vaginal invagination will be described and its clinical presentation will be intraoperatively recorded.
The vaginal invagination will be released as required to proceed with the prolapse surgery. Patient will be followed up 6 weeks and 3 months postoperatively
Intervention code [1] 257767 0
Not applicable
Comparator / control treatment
No control group is required. This would be the first description in literature of vaginal invagination.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259840 0
Description and clinical presentation of vaginal invagination in women undergoing vaginal prolapse surgery
Timepoint [1] 259840 0
A vaginal invagination can only be detected intraoperatively.
An audit will be held as routinely performed in women undergoing prolapse surgery 6 weeks postoperatively.
Secondary outcome [1] 268699 0
Assessment of the outcome of the surgical intervention. Patients will be examined according to the ICS POP-Q system (tool to assess the pelvic floor) and patient will be asked to complete the Queensland Pelvic Floor Questionnaire before and after surgery. All patients undergoing pelvic floor surgery are asked to complete this questionnaire and are examined accoriding to the ICS POP-Q system.
Timepoint [1] 268699 0
baseline (intraoperatively) and 6 weeks postoperatively.

Eligibility
Key inclusion criteria
Women undergoing vaginal prolapse surgery with a intraoperative detected vaginal invagination will be included in this observational study.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
This is only an observational study to describe the condition of vaginal invagination. All women will be asked postoperatively to participated for an audit. Patients can withdraw from the study at any time.

Study design
Purpose
Natural history
Duration
Cross-sectional
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] 258231 0
Self funded/Unfunded
Name [1] 258231 0
Country [1] 258231 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] 257398 0
None
Name [1] 257398 0
Address [1] 257398 0
Country [1] 257398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260211 0
Institutional Review Board (IRB) for Low and Negligible Risk Research, RBWH, Queensland Health
Ethics committee address [1] 260211 0
Royal Brisbane and Womens Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 260211 0
Australia
Date submitted for ethics approval [1] 260211 0
Approval date [1] 260211 0
22/11/2010
Ethics approval number [1] 260211 0

Summary
Brief summary
The purpose of this observational project is to identify patients with a vaginal invagination and report the clinical presentation of a series of 20 patients undergoing prolapse surgery. This observational study is conduced to obtain a better understanding of the pathophysiology of the vagina after repeat gynaecological surgery.
The hypothesis of this study is that women undergoing prolapse surgery who have had previous pelvic floor surgery are at high risk to present with a vaginal invagination due to incorrect restoring of the normal anatomy of the vagina. Vaginal invagination are likely to be caused by inappropriate surgical techniques and lack of awareness of this subsequent condition. By identification and in the following surgical releasing of the vaginal invagination this might create a better anatomical setting to perform further prolapse surgery. Furthermore it might have an impact on preexisting pain, dysparunia or shortend vagina.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32029 0
Address 32029 0
Country 32029 0
Phone 32029 0
Fax 32029 0
Email 32029 0
Contact person for public queries
Name 15276 0
Corina Schmid
Address 15276 0
Department of Urogynaecology RBWH
Butterfield Street
Herston
QLD 4029
Country 15276 0
Australia
Phone 15276 0
+61 (0)44 9822896
Fax 15276 0
Email 15276 0
cocoschmid@hotmail.com
Contact person for scientific queries
Name 6204 0
Corina Schmid
Address 6204 0
Department of Urogynaecology RBWH
Butterfield Street
Herston
QLD 4029
Country 6204 0
Australia
Phone 6204 0
+61 (0)44 982289 6
Fax 6204 0
Email 6204 0
cocoschmid@hotmail.com

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

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