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Trial registered on ANZCTR


Registration number
ACTRN12610000002088
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
5/01/2010
Date last updated
5/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Gynecel Trial for Pelvic Floor Reconstruction using a Biomaterial Mesh in women with symptomatic anterior vaginal wall prolapse
Scientific title
Assessment of the ADAPT Tissue Engineered Process Treated Bovine Pericardial Patch for Pelvic Floor Reconstruction in women with symptomatic anterior vaginal wall prolapse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior vaginal wall prolapse 243810 0
Condition category
Condition code
Surgery 239983 239983 0 0
Other surgery
Renal and Urogenital 240008 240008 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the tissue regeneration efficacy and safety of the ADAPT (a new anti-calcification process for xenogenic tissue) treated bovine pericardial patch (BPP) in a pelvic floor reconstruction procedure.
The ADAPT treated bovine pericardial patch will be placed as follows:
General or regional anaesthesia may be administered according to the surgeon/anaesthetist preference.
The patient is placed in the lithotomy position, with the buttocks slightly overhanging the table, followed by standard antiseptic preparation of the vulva and vaginal skin.
Antibiotic prophylaxis is administered.
The anterior wall vaginal incision is made vertically from approximately 1 cm below the cervix (or vault) ending approximately 2-3 cm from the bladder neck.
The anterior vaginal wall edges are grasped with retraction hooks to maintain traction whilst a dissection of the vaginal wall is performed. The pubocervical fascia will be maintained on the vaginal wall.
The dissection will be continued lateral to the bladder on each side into the paravesical space, creating a broad space lateral to the bladder with the aim of identifying the entirety of the arcus tendineus fasciae pelvis (ATFP), which extends from the posterior aspect of the pubic arch to the ischial spine.
The Gynecel patch will then be fashioned to insert into this dissected space, with the aim of a tension-free attachment of each side of the patch to the ATFP on each pelvic side wall.

The anterior and posterior aspects of the mesh will be stabilised in place by 2.0 Monocryl sutures at the bladder neck and the vault respectively, and the lateral edges attaching to the ATFP will be secured by Vicryl or titanium tacks, or sutures.

Trimming of redundant vaginal skin is not advised.

The vaginal skin incision is then repaired with 2.0 Vicryl with a continuous locking suture.
A vaginal pack and urinary catheter are inserted at the end of the procedure for till the next morning.

The procedure will take approximately 1 hour to perform, and is performed once only on each patient.

The patient is retained as an in-patient and will follow the standard trial of void protocol of the Unit upon removal of the vaginal pack and catheter to identify any voiding dysfunction problems that may occur.

The primary objectives are to evaluate the safety, efficacy and clinical performance of the ADAPT BPP.
The above parameters will be assessed by documentation of:
1. Device related complication issues – which will be assessed by monitoring device implantation issues (intra-operatively), device strength and durability, device failure (as evidenced by recurrence of subsequent anterior vaginal wall prolapse)and post-operative infection rates.
2. Early (<30 days) morbidity – including haemorrhage (>500mls), blood transfusion, infection, bladder injury.
3. Long-term (up to 12 months) morbidity – including chronic infection, ulceration, calcification of the device, recurrence of prolapse.
2.2 Secondary Objectives
The secondary objectives are to evaluate:
1. Design features – which will be assessed by monitoring use of the device intra-operatively, by allocating a score out of 10 for handling characteristics and shape and sizing characteristics, and recording associated suture/staple used to fix the device.
2. Objective Clinical Results – this will be assessed by objective measurement of the position of Point Aa (anterior wall 3cm proximal to the hymen) and Point Ba (leading-most point of anterior vaginal wall prolapse) by Pelvic Organ Quantification (POP-Q) score pre-operatively, and then at 6 weeks, 6 months and 1 year post-operatively.
3. Subjective Clinical Results – the validated Pelvic Floor Distress Inventory - Short Form 20 (PFDI-SF 20) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) will be used pre- and post-operatively to assess patients’ functional status.
Intervention code [1] 241271 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240880 0
Device-related complication issues
- including device implantation issues (recorded at time of insertion), device strength and durability, device failure (assessed by timing and frequency of recurrence of anterior vaginal wall prolapse post-operatively) and post-operative infection rates.
Timepoint [1] 240880 0
At time of surgery
6 weeks, 6 months, 12 months and 24 months post-operatively
Primary outcome [2] 240881 0
Early morbidity (<30 days post-operatively))
- including haemorrhage (>500 mls), blood transfusion and infective morbidity, bladder injury
- assessed by intra-operative documentation and patient follow-up at 6 weeks post-operative visit which will include vaginal examination
Timepoint [2] 240881 0
Immediate post-operative period and up to 30 days post-operatively
Primary outcome [3] 240882 0
Long-term morbidity (up to 2 years post-operatively)) including chronic infection, ulceration, calcification of the device, recurrence of prolapse
- assessed by patient follow-up at 6 months, 1 year and 2 years post-operative visit which will include vaginal examination
Timepoint [3] 240882 0
6, 12 and 24 months post-operatively
Secondary outcome [1] 257549 0
Design features including handling characteristics of the device, sizing and shaping characteristics and associated suture/staple used to fix the device in place
- above qualities will be scored out of 10 by the operator
Timepoint [1] 257549 0
At time of surgery
Secondary outcome [2] 257550 0
Objective Clinical Results determined by measurement of the point Aa (anterior vaginal wall 3cm proximal to the hymen) and point Ba (leading-most point of anterior vaginal wall prolapse) by Pelvic Organ Prolapse Quantification (POP-Q) score.
Timepoint [2] 257550 0
Pre-operatively
At time of surgery
6 weeks post-operatively
6, 12 and 24 months post-operatively
Secondary outcome [3] 257551 0
Subjective Clinical Results - the validated Pelvic Floor Distress Inventory Short Form 20 (PFDI- SF20) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
Timepoint [3] 257551 0
Pre-operatively
At time of surgery
6 weeks post-operatively
6, 12 and 24 months post-operatively

Eligibility
Key inclusion criteria
Women with symptomatic pelvic organ prolapse of POP-Q Stage II - IV, suitable for surgery
Post-menopausal state
Minimum age
50 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous repair of pelvic organ prolapse involving insertion of mesh
Pregnant or intending future pregnancy
Morbid obesity > 110kg
Body Mass Index >30
Active genital/urinary/systemic infection at the time of surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be selected based on the requirement for pelvic floor reconstruction with use of mesh support, where substitution of the ADAPT treated BPP will be possible. We have decided to select anterior vaginal wall prolapse reconstruction only as the procedure to be examined as this will limit the variables in such a small group for the purposes of comparison
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 243710 0
Commercial sector/Industry
Name [1] 243710 0
Celxcel Pty Ltd
Address [1] 243710 0
Level 11, 225 St George's Terrace,
Perth,
Western Australia 6000
Country [1] 243710 0
Australia
Primary sponsor type
Individual
Name
Dr Gregory M Cario
Address
Level 3
St George Private Hospital,
1 South Street
Kogarah,
NSW 2217
Country
Australia
Secondary sponsor category [1] 237073 0
Hospital
Name [1] 237073 0
St George Hospital
Address [1] 237073 0
Gray Street,
Kogarah,
NSW 2217
Country [1] 237073 0
Australia
Other collaborator category [1] 850 0
Individual
Name [1] 850 0
Aoife O' Neill
Address [1] 850 0
Women and Children's Health,
St George Hospital,
Gray Street,
Kogarah,
NSW 2217
Country [1] 850 0
Australia
Other collaborator category [2] 851 0
Individual
Name [2] 851 0
Dr David Rosen
Address [2] 851 0
Level 3
St George Private Hospital,
1 South Street,
Kogarah,
NSW 2217
Country [2] 851 0
Australia
Other collaborator category [3] 852 0
Individual
Name [3] 852 0
Dr Danny Chou
Address [3] 852 0
Level 5
St George Private Hospital,
1 South Street,
Kogarah,
NSW 2217
Country [3] 852 0
Australia
Other collaborator category [4] 858 0
Individual
Name [4] 858 0
Thomas Aust
Address [4] 858 0
Women and Children's Health,
Gray Street,
Kogarah,
NSW 2217
Country [4] 858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243840 0
South Eastern Sydney/Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [1] 243840 0
St George Hospital,
James Laws House,
Gray Street,
Kogarah,
NSW 2217
Ethics committee country [1] 243840 0
Australia
Date submitted for ethics approval [1] 243840 0
Approval date [1] 243840 0
Ethics approval number [1] 243840 0
09/STG/73

Summary
Brief summary
Reconstructive pelvic floor surgery to treat vaginal prolapse problems can often require the use of a supportive mesh or biomaterial, and currently we use a synthetic, non-absorbable polypropylene mesh. However, synthetic mesh use can be associated with complications, such as mesh erosion. The currently used synthetic meshes have reported rates of erosion (protrusion of mesh material through vaginal skin or bladder) of 9-13%, while studies show virtually no reports of erosion with use of biologic meshes. Mesh erosion can require further surgery to remove the protruding mesh. bioMD, (a company who produces biologic meshes or patches) has a new biomaterial that is appropriate for pelvic floor reconstruction. The new biomaterial will be used instead of the currently used synthetic mesh. It has been called a biomaterial as it is made from treated tissue sourced from around the heart of a cow (the pericardium). This biomaterial will be used to provide support for the pelvic floor.
The aim of this study is therefore to first test the new biomaterial in 20 patients who require the use of such a biomaterial during prolapse surgery. This testing will enable us to identify that this biomaterial is effective at treating vaginal prolapse, and allow us to assess any associated complications with its use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30266 0
Address 30266 0
Country 30266 0
Phone 30266 0
Fax 30266 0
Email 30266 0
Contact person for public queries
Name 13513 0
Dr Aoife O' Neill
Address 13513 0
Women and Children's Health,
St George Hospital,
Gray Street,
Kogarah,
NSW 2217
Country 13513 0
Australia
Phone 13513 0
+612 9598 5522
Fax 13513 0
+612 9598 5524
Email 13513 0
aoifeon@gmail.com
Contact person for scientific queries
Name 4441 0
Dr Greg Cario
Address 4441 0
Sydney Women's Endosurgery Centre
Ground Floor
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country 4441 0
Australia
Phone 4441 0
+612 9598 5522
Fax 4441 0
+612 9598 5524
Email 4441 0
aoifeon@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results