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Trial registered on ANZCTR


Registration number
ACTRN12616000159459
Ethics application status
Approved
Date submitted
13/11/2015
Date registered
10/02/2016
Date last updated
14/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy.
Scientific title
Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy evaluating at one-year: recurrence, quality of life and need for re-operation on anterior pelvic organ prolapse.
Secondary ID [1] 287884 0
Nil
Universal Trial Number (UTN)
Trial acronym
APOP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 296769 0
Condition category
Condition code
Surgery 297003 297003 0 0
Surgical techniques
Renal and Urogenital 297004 297004 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Xenform anterior repair
The procedure for standardised Xenform anterior repair is as follows. Vaginal sub-epithelial layer infiltrated with local anaesthetic/saline solution to aid hydrodissection in the sub-epithelial fascial layer. After midline vertical skin incision a full skin thickness dissection of the anterior vaginal wall made from the level of bladder neck to the vaginal apex and bilaterally to each vaginal sulcus. The endopelvic fascia is reinforced by standard midline plication with 2-0 polydioxanone suture. A 10" by 7" Xenform graft is shaped to make an anterior based sacrospinous graft. Graft arms anchored to sacrospinous ligament with a Capio suturing device using 0 Monodec suture. The graft is tacked to vaginal sulci, apex and bladder neck plus 2 central sutures over the midline fascial plication.using 2.0 PDS. Vagina is closed with a single locking 2-0 polyglactin suture. Cystourethroscopy after intravenous Indigo carmine is performed.
Performed by Urogynaecologist or urogynaecology fellow
Duration 45-60 minutes
Intervention code [1] 293250 0
Treatment: Surgery
Comparator / control treatment
Anterior colporrhaphy
The procedure for standardised anterior colporrhaphy is as follows. Vaginal epithelium infiltrated with local anaesthetic/saline solution to aid hydro-dissection within the vaginal epithelial layer. After midline vertical skin incision a partial skin thickness dissection of the anterior vaginal is made vertically from the level of bladder neck to the vaginal apex and bilaterally to each vaginal sulcus. The endopelvic fascia is reinforced by standard midline plication with 2-0 polydioxanone suture. Interrupted lateral sulci sutures of 2-0 polydioxanone from the level of the bladder neck to the vaginal apex. Vaginal epithelium will be trimmed as required and closed with a single locking 2-0 polyglactin suture. Cystourethroscopy after intravenous indigo carmine is performed.
Performed by Urogynaecologist or urogynaecology fellow
Duration 30-45 minutes
Control group
Active

Outcomes
Primary outcome [1] 296599 0
Success is defined as meeting all three criteria in a composite outcome at one year:
1. Point Ba less than or equal to 0 (POP-Q) AND
2. A response of 0 or 1 to the question “Do you usually have a bulge or something falling out that you can see of feel in your vaginal area?” (Question 3 of the Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20) AND
3. No reoperation for anterior vaginal wall prolapse.
Timepoint [1] 296599 0
One year post operative
Secondary outcome [1] 318852 0
Most distal position of upper anterior vaginal relative to hymen (Point Ba using POP-Q method)
Timepoint [1] 318852 0
One year post operative
Secondary outcome [2] 318853 0
Response to the question “Do you usually have a bulge or something falling out that you can see of feel in your vaginal area?” (Question 3 of the Pelvic Floor Distress Inventory-Short Form 20)
Timepoint [2] 318853 0
One year post operative
Secondary outcome [3] 318854 0
No reoperation for anterior POP. Assessed by review of hospital records and patient history
Timepoint [3] 318854 0
One year post operative
Secondary outcome [4] 318855 0
Quality of Life as assessed by total score of Pelvic Floor Distress Inventory-Short Form 20
Timepoint [4] 318855 0
One year post operative
Secondary outcome [5] 318856 0
Postoperative complications such as bowel injury, bladder injury, estimated blood loss > 500mL, intra-operative laparotomy, unplanned return to theatre.

Assessed by review of hospital records
Timepoint [5] 318856 0
Intraoperatively to hospital discharge
Secondary outcome [6] 320552 0
Urinary tract infection, urinary retention treated with catheter, vaginal wound bleeding, vaginal epithelium separation or ulcer, vaginal graft exposure, pelvic pain, surgery for prolapse recurrence

Assessed by review of hospital records
Timepoint [6] 320552 0
Hospital discharge to 2 months and 2 months to one year

Eligibility
Key inclusion criteria
1. Symptomatic anterior POP at or beyond hymen (point Ba greater than or equal to 0) AND
2. Desire for surgery
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous POP surgery with implant in target compartment OR
2. Age less than 40 years OR
3. Unfinished family OR
4. Connective tissue disease OR
5. Uncontrolled diabetes OR
6. Prior pelvic radiation OR
7. Vaginal ulceration OR
8. Apical vaginal compartment warranting targeted vault colpopexy

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 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?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 92 per group has approximately 80% power to detect a 15% difference between treatment groups in the binary composite outcome, based on a 77% success rate in the control group at one year after surgery (obtained from local hospital audit), with an alpha level at 0.05 (PASS Power and Sample Size Program for Windows 2011, version 8.1, Kayesville Utah). To allow for 15% loss to follow up, a total sample size of 212 will be recruited.

Frequency distributions and means and standard deviations or medians and interquartile ranges will be used to summarise categorical and continuous data, as appropriate. Chi-square or Fisher exact tests will be used to compare categorical outcomes between treatment groups, and t-tests or Mann-Whitney tests performed for comparisons of continuous outcomes. One interim analysis will be performed, anticipated to occur halfway through the study period, using the O’Brien-Fleming spending function to determine the test boundaries. The nominal significance level at the first sequential test is 0.003 and at the final test is 0.049.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
TGA withdrawal of Xenform from use in vaginal surgery
Date of first participant enrolment
Anticipated
11/02/2016
Actual
Date of last participant enrolment
Anticipated
1/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4624 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [2] 4625 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [3] 4626 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [4] 4627 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [5] 4628 0
South Perth Hospital - South Perth
Recruitment postcode(s) [1] 12215 0
6008 - Subiaco
Recruitment postcode(s) [2] 12216 0
6009 - Nedlands
Recruitment postcode(s) [3] 12217 0
6150 - Murdoch
Recruitment postcode(s) [4] 12218 0
6151 - South Perth

Funding & Sponsors
Funding source category [1] 292381 0
Self funded/Unfunded
Name [1] 292381 0
No funding
Country [1] 292381 0
Primary sponsor type
Individual
Name
Dr Todd Ladanchuk
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 291068 0
Individual
Name [1] 291068 0
Dr Michelle Atherton
Address [1] 291068 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country [1] 291068 0
Australia
Other collaborator category [1] 278699 0
Individual
Name [1] 278699 0
Dr Nicolas Tsokas
Address [1] 278699 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country [1] 278699 0
Australia
Other collaborator category [2] 278700 0
Individual
Name [2] 278700 0
Dr J Phillipe Daborn
Address [2] 278700 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country [2] 278700 0
Australia
Other collaborator category [3] 278701 0
Individual
Name [3] 278701 0
Dr Tim Jeffery
Address [3] 278701 0
St John of God Hospital, Subiaco
12 Salvado Road
Subiaco
6008
Western Australia
Country [3] 278701 0
Australia
Other collaborator category [4] 278702 0
Individual
Name [4] 278702 0
Dr C Pierre Smith
Address [4] 278702 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country [4] 278702 0
Australia
Other collaborator category [5] 278703 0
Individual
Name [5] 278703 0
Dr Katherine Penrose
Address [5] 278703 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco 6008
Western Australia
Country [5] 278703 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293851 0
Women and Newborn Health Service Ethics Committee
Ethics committee address [1] 293851 0
374 Bagot Road
Subiaco 6008
Western Australia
Ethics committee country [1] 293851 0
Australia
Date submitted for ethics approval [1] 293851 0
03/11/2015
Approval date [1] 293851 0
08/12/2015
Ethics approval number [1] 293851 0
2015228EW
Ethics committee name [2] 293853 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [2] 293853 0
Hollywood Private Hospital
Locked Bag 2002
NEDLANDS WA 6909
Ethics committee country [2] 293853 0
Australia
Date submitted for ethics approval [2] 293853 0
13/11/2015
Approval date [2] 293853 0
14/01/2016
Ethics approval number [2] 293853 0
HPH442
Ethics committee name [3] 293854 0
St John of God Health Care Human Research Ethics Committee ETHICS COMMITTEE
Ethics committee address [3] 293854 0
St John of God Subiaco Hospital
12 Salvado Rd
SUBIACO WA 6008
Ethics committee country [3] 293854 0
Australia
Date submitted for ethics approval [3] 293854 0
27/11/2015
Approval date [3] 293854 0
Ethics approval number [3] 293854 0

Summary
Brief summary
Female anterior pelvic organ prolapse (POP) is common. In POP, the vaginal tissues become weak, causing descent of vaginal walls. In moderate to severe anterior POP, conservative treatments may be unsuccessful. In these cases surgical treatments can include:
*Surgical repair with a patient’s own tissue (anterior colporrhaphy)
*Surgical repair with reinforcement using a tissue graft to provide additional support.

The aim of this study is to compare two established surgical techniques for anterior POP to determine which has the best result. The primary outcome will be measured using the following criteria. All three must be met qualify as success: 1) objective measures (anatomical), 2) subjective measures (validated quality of life questionnaire), 3) participant not having repeat procedure for anterior POP recurrence. The primary outcome will be assessed at one year after surgery.

This is a multicentre blinded prospective randomised trial. Participants will be randomised to:
1. Anterior colporrhaphy
2. Xenform anterior vaginal repair
Both procedures are routinely performed by urogynaecologists in the private and public sectors.

Xenform Matrix (Boston Scientific, Marlborough, MA, USA) is used in Australia and by the urogynaecologists in Perth in the private and public sectors for surgical repair of POP. Xenform has been approved since 2010 for POP repair by the Australian Therapeutic Goods Administration.

For the participants at Hollywood Private Hospital, they will be recruited from the surgeon’s private rooms. Participants will be eligible if they have symptomatic anterior POP to the level of the hymen and desire surgical treatment. At recruitment, participants will have a pelvic examination to assess pelvic organ prolapse quantification (POP-Q as per International Continence Society). A validated quality of life questionnaire (QoL) (Pelvic Floor Distress Inventory Short Form 20) will also be administered. POP-Q and PFDI-20 will be repeated one year after the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61514 0
Dr Todd Ladanchuk
Address 61514 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Western Australia
6008
Country 61514 0
Australia
Phone 61514 0
+61(8)93402222
Fax 61514 0
Email 61514 0
todd.ladanchuk@health.wa.gov.au
Contact person for public queries
Name 61515 0
Todd Ladanchuk
Address 61515 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Western Australia
6008
Country 61515 0
Australia
Phone 61515 0
+61(8)93402222
Fax 61515 0
Email 61515 0
todd.ladanchuk@health.wa.gov.au
Contact person for scientific queries
Name 61516 0
Todd Ladanchuk
Address 61516 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Western Australia
6008
Country 61516 0
Australia
Phone 61516 0
+61(8)93402222
Fax 61516 0
Email 61516 0
todd.ladanchuk@health.wa.gov.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
SourceTitleYear of PublicationDOI
EmbaseSurgery for women with anterior compartment prolapse.2016https://dx.doi.org/10.1002/14651858.CD004014.pub6
N.B. These documents automatically identified may not have been verified by the study sponsor.