Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000797178p
Ethics application status
Not yet submitted
Date submitted
23/05/2019
Date registered
30/05/2019
Date last updated
2/09/2019
Date data sharing statement initially provided
30/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic Tissue Fixation System (TFS) uterosacral ligament repair in patients with uterine prolapse.
Scientific title
Laparoscopic Tissue Fixation System (TFS) uterosacral ligament repair in patients with uterine prolapse.
Secondary ID [1] 298275 0
NONE
Secondary ID [2] 298316 0
NA
Universal Trial Number (UTN)
U1111-1233-6590
Trial acronym
NONE
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
female organ prolapse 312884 0
Condition category
Condition code
Reproductive Health and Childbirth 311445 311445 0 0
Other reproductive health and childbirth disorders
Surgery 311447 311447 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is via standard laparoscopic equipment using two laterally sited canulas. There is one intervention, average duration one hour. The uterosacral ligaments (USL) are identified, held and penetrated with dissecting scissors to form a tunnel 5cm long inside the USL. The implant device consists of a purposely knitted polypropylene tape 7mm wide inserted into the base of an anchor 11mmx4,mm with 4 prongs. At the base of the anchor is a trapdoor-like arrangement through which the tape passes. This is a one-way system which allows the tape to be precisely tightened. This action also shortens the ligament. The tapes areinserted into each USL and the sling is tightened. The tape remains in situ permanently. A copy of all materials provided to the patients describing the lap intervention’’German language will be provided to ANZCTR in due course -
- a surgeon from Feldkirk Austria will deliver the intervention. The surgeon has a 25 year surgical experience.
- explanation of the intervention will be provided by the surgeon in a face to face pre-operative interview with each patient.

- the intervention will be in the Feldkirk Hospital, Austria
Intervention code [1] 314517 0
Treatment: Surgery
Intervention code [2] 314587 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320111 0
correction of the uterine or apical prolapse
This will be assessed using the POPQ classification system
Timepoint [1] 320111 0
6 weeks post-operative
Secondary outcome [1] 370554 0
correction of pre-operative symptoms of bladder, bowel, pain
These will be assessed by a validated ITSQ (Integral Theory Symptom Questionnaire) questionnaire administered before and 6 weeks after the surgery
The ITSQ covers all these3 symptoms
This is a composite outcome.
Timepoint [1] 370554 0
6 weeks post-operative

Eligibility
Key inclusion criteria
All female patients with symptomatic prolapse
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Collateral illnesses sufficient to prevent safe 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)
not applicable
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
Efficacy
Statistical methods / analysis
Statistical analysis
Paired binary response data (per-patient presence/absence of a specific sign/symptom before vs. after surgery) in the total study cohort were analyzed with a McNemar’s test, with a null hypothesis of no treatment effect.
The GraphPad Quickcalcs platform was used for this analysis (http://graphpad.com/quickcalcs/mcNemar1/). The sample size (https://www.statstodo.com/SSizMcNemar_Pgm.php) was deemed sufficient to assume a Chi-squared distribution. The Chi-square was calculated with one degree of freedom.
Post-hoc estimation of the study power was performed, assuming an alpha error equal to 0.01 (https://www.statstodo.com/SSizMcNemar_Pgm.php). In all cases the estimated power for this comparison exceeded 0.95.

To evaluate differences between the proportions of patients showing or not a specific sign/symptom when treated with TFS USL tensioned sling, the Z-ratio and the 95% confidence interval for the difference between independent proportions calculated .

The VassarStats platform was used for this analysis (www.vassarstats.net).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
LOGISTICS
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21494 0
Austria
State/province [1] 21494 0
Feldkirk

Funding & Sponsors
Funding source category [1] 302816 0
Hospital
Name [1] 302816 0
Feldkirk Hospital
Country [1] 302816 0
Austria
Primary sponsor type
Hospital
Name
Akademisches Lehrkrankenhaus Feldkirch
Address
Akademisches Lehrkrankenhaus Feldkirch
6800 Feldkirch, Carinagasse 47
Austria
Country
Austria
Secondary sponsor category [1] 302766 0
None
Name [1] 302766 0
Address [1] 302766 0
Country [1] 302766 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303400 0
IRB Akademisches Lehrkrankenhaus Feldkirch
Ethics committee address [1] 303400 0

Akademisches Lehrkrankenhaus Feldkirch
6800 Feldkirch, Carinagasse 47
Austria
Ethics committee country [1] 303400 0
Austria
Date submitted for ethics approval [1] 303400 0
22/05/2019
Approval date [1] 303400 0
Ethics approval number [1] 303400 0

Summary
Brief summary
The aim is to create a more anatomical, safer and less invasive method for repairing uterine/apical prolapse. At present laparoscopic sacrocolpopexy is performed by attachment of the apex to the sacral promontory. This method is not anatomical and may cause difficulties with bladder and bowel evacuation post-operatively. The approach to the uterosacral likgamegts is by either side of the abdomen. Each USL is located. The USL is tensioned by pulling the uterus downwards.The USL is entered and a 5cm tunnel is made. Each anchor is inserted in turn and then tensioned via the TFS one-way system to elevate the prolapsed uterus or apex.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93542 0
Prof Burghard Abendstein
Address 93542 0

Akademisches Lehrkrankenhaus Feldkirch
6800 Feldkirch, Carinagasse 47
Austria
Country 93542 0
Austria
Phone 93542 0
+43-5522-303-2201
Fax 93542 0
Email 93542 0
burghard.abendstein@vlkh.net
Contact person for public queries
Name 93543 0
Peter Emanuel Petros
Address 93543 0
C/O School of Engineering
University of Western Australia
Stirling Highway
Crawley
WA
6009
Country 93543 0
Australia
Phone 93543 0
+61 411 181 731
Fax 93543 0
Email 93543 0
pp@kvinno.com
Contact person for scientific queries
Name 93544 0
Burghard Abendstein
Address 93544 0

Akademisches Lehrkrankenhaus Feldkirch
6800 Feldkirch, Carinagasse 47
Austria
Country 93544 0
Austria
Phone 93544 0
+43-5522-303-2201
Fax 93544 0
Email 93544 0
burghard.abendstein@vlkh.net

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results
When will data be available (start and end dates)?
1/1/2021- but no end date for when data will be available
Available to whom?
other researchers
Available for what types of analyses?
clinical and statistical
How or where can data be obtained?
Principal investigator by email


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.