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Trial registered on ANZCTR


Registration number
ACTRN12612000236897
Ethics application status
Approved
Date submitted
21/02/2012
Date registered
24/02/2012
Date last updated
8/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Puborectalis Sling RCT - a study on reducing pelvic organ prolapse recurrences following prolapse surgery.
Scientific title
Reducing the levator hiatus with a puborectalis sling - a multi centre randomised controlled trial for patients undergoing pelvic organ prolapse surgery
Secondary ID [1] 279997 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ prolapse 285905 0
Condition category
Condition code
Renal and Urogenital 286097 286097 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised Controlled trial - 2 arms.
One arm - patients undergoing standard pelvic organ prolapse repair surgery which may include a combination of vaginal hysterectomy, anterior +/- posterior vaginal wall repair, sacrospinous fixation +/- anti-incontinence procedures. In total, the procedure may vary from 60 minutes to 120 minutes.
Intervention arm - patients undergoing standard pelvic organ prolapse repair ( as per above) will receive in addition, a puborectalis sling insertion, which is an additional 3x15cm strip of polypropylene mesh inserted via the obturator foramen, traversing the ischio-rectal fossa and post-anally from one side to the other. This additional mesh insertion may require an additional 15 - 30 minutes of surgical operating time.
Intervention code [1] 284323 0
Treatment: Surgery
Comparator / control treatment
Standard or Routine pelvic organ prolapse surgical repair which may incorporate vaginal hysterectomy, anterior or posterior vaginal repair with or without mesh reinforcement. In addition, patients may also receive additional anti-incontinence surgery as necessary according to pre-operative diagnosis
Control group
Active

Outcomes
Primary outcome [1] 286572 0
Recurrent prolapse on transperineal ultrasound imaging
ie. Cystocele at >/= 10mm below the symphysis pubis, Enterocele or cervix at >/= 0mm below the symphysis pubis and Rectocele at >/= 15mm below the symphysis pubis
Timepoint [1] 286572 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedures
Secondary outcome [1] 296200 0
Ultrasound findings of levator hiatal area
Timepoint [1] 296200 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedure
Secondary outcome [2] 296201 0
Questionnaire scores - (ICIQ-VS, PFDI) to assess for prolapse symptoms and its association with urinary and bowel function
Timepoint [2] 296201 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedure
Secondary outcome [3] 296243 0
Questionnaire scores - (PIQ-6) to assess for pain and it's impact on quality of life
Timepoint [3] 296243 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedure
Secondary outcome [4] 296244 0
Questionnaire scores - (PSIQ-12) to assess for sexual function
Timepoint [4] 296244 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedure
Secondary outcome [5] 296199 0
Prolapse recurrence - either with symptoms of vaginal bulge or lump, Clinical prolapse recurrence ( ie >/= Stage 2) on POPQ assessment
Timepoint [5] 296199 0
6 weeks, 3 months, 6 months and annually thereafter for 5 years post-procedure

Eligibility
Key inclusion criteria
All patients undergoing conventional/standard pelvic organ prolapse surgery with an enlarged levator hiatus (>30cm2) and have completed family
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Overt neuromuscular abnormality, Levator hiatus of <30cm2, Inability to attend follow-up or comply with study protocol or inability to give informed consent and patients who are still intending on future pregnancies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited directly by participating surgeons. Randomisation will occur just prior to surgery, with a central office co-ordinating block randomisation with sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5023 0
3144
Recruitment postcode(s) [2] 5022 0
4810
Recruitment postcode(s) [3] 5019 0
2750
Recruitment postcode(s) [4] 5020 0
2050
Recruitment postcode(s) [5] 5021 0
2217
Recruitment postcode(s) [6] 5024 0
4120

Funding & Sponsors
Funding source category [1] 284756 0
Charities/Societies/Foundations
Name [1] 284756 0
RANZCOG
Country [1] 284756 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Nepean Hospital
Derby Street, Penrith
NSW 2750
Country
Australia
Secondary sponsor category [1] 283647 0
None
Name [1] 283647 0
Address [1] 283647 0
Country [1] 283647 0
Other collaborator category [1] 260564 0
Individual
Name [1] 260564 0
Prof Anna Rosamilia
Address [1] 260564 0
Monash Medical Centre
Suite 8, Cabrini Medical Centre
183 Wattletree Road
Melbourne, Victoria 3144
Country [1] 260564 0
Australia
Other collaborator category [2] 260562 0
Individual
Name [2] 260562 0
Prof Andrew Korda
Address [2] 260562 0
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050
Country [2] 260562 0
Australia
Other collaborator category [3] 260565 0
Individual
Name [3] 260565 0
Prof Judith Goh
Address [3] 260565 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Greenslopes, Queensland 4120
Country [3] 260565 0
Australia
Other collaborator category [4] 260561 0
Individual
Name [4] 260561 0
Prof Kate Moore
Address [4] 260561 0
St George Hospital
Belgrave Street, Kogarah
NSW 2217
Country [4] 260561 0
Australia
Other collaborator category [5] 260563 0
Individual
Name [5] 260563 0
Prof Ajay Rane
Address [5] 260563 0
Townsville Hospital
POBOX 1417
Thuringowa Central, Townsville
Queensland 4817
Country [5] 260563 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286755 0
Nepean Blue Mountains LHD HREC
Ethics committee address [1] 286755 0
Ethics committee country [1] 286755 0
Australia
Date submitted for ethics approval [1] 286755 0
Approval date [1] 286755 0
29/09/2011
Ethics approval number [1] 286755 0
HREC/11/NEPEAN/54

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33815 0
Address 33815 0
Country 33815 0
Phone 33815 0
Fax 33815 0
Email 33815 0
Contact person for public queries
Name 17062 0
Prof Hans Peter Dietz
Address 17062 0
Nepean Hospital
Level 5, Spurrett Bldg
Derby Street
Penrith, NSW 2750
Country 17062 0
Australia
Phone 17062 0
(+61)247341474
Fax 17062 0
(+61)247341817
Email 17062 0
hpdietz@med.usyd.edu.au
Contact person for scientific queries
Name 7990 0
Prof Hans Peter Dietz
Address 7990 0
Nepean Hospital
Level 5, Spurrett Bldg
Derby Street
Penrith, NSW 2750
Country 7990 0
Australia
Phone 7990 0
(+61)247341474
Fax 7990 0
(+61)247341817
Email 7990 0
hpdietz@med.usyd.edu.au

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
No additional documents have been identified.