Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000119291
Ethics application status
Approved
Date submitted
23/01/2009
Date registered
19/02/2009
Date last updated
19/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laparoscopic verus vaginal mesh surgery in the management of post-hysterectomy vaginal vault prolapse
Scientific title
laparoscopic sacral colpopexy versus total vaginal mesh in the treatment of vaginal vault prolapse assessing anatomical outcomes
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post hysterectomy vaginal vault prolapse 4228 0
Condition category
Condition code
Surgery 4448 4448 0 0
Surgical techniques
Renal and Urogenital 4595 4595 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the vaginal group will undergo a total vaginal mesh repair ( prolift Johnson and Johnson Gynecare). In those with preoperative stress urinary incontinence a Tension free Vaginal Tape- obturator (TVTO) will be performed. This surgery is all performed vaginally and this is a once only procedure.
Intervention code [1] 3946 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic sacral colpopexy: involves securing the vaginal vault to the sacral prominetry using a permanent polypropylene mesh (Prolene, Johnson and Johnson Gynecare). This is a once only surgery performed thru mini incisions in the abdomen (Key-hole surgery)
Control group
Active

Outcomes
Primary outcome [1] 5471 0
recurrence of Pelvic organ prolapse on examination using the pelvic organ prolapse quantification (POP-Q) system
Timepoint [1] 5471 0
patients examined six weeks, six months and yearly there after. Reporting of outcomes will occur at 2 and 5-years.
Patients will be examined at these visits and complete POP-Q by a reviewer unaware of which procedure has been performed.
Secondary outcome [1] 8960 0
quality of life outcomes: Tools questionnaires Queensland Pelvic floor questionnaire (QPFQ) and Prolapse Quality of life (P-QOL) questionnaire
Timepoint [1] 8960 0
6 months, 1, 2,3,4,5 years
Secondary outcome [2] 9212 0
complication rate: example would be mesh erosions that would be detected on scheduled examinations.
Timepoint [2] 9212 0
at all reviews 6 weeks, 6 months, 1,2,3,4 years
Secondary outcome [3] 9213 0
subjective success rate: Question are you aware of any vaginal prolapse?
Timepoint [3] 9213 0
6weeks, 6 months, 1,2,3,4 years

Eligibility
Key inclusion criteria
women with symptomatic post hysterectomy vaginal vault prolapse (POPQ stage 2 Point C greater than or equal to -1
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body mass index (BMI) greater than 35
not able to consent or follow-up
previous laparotomy greater than 4
Prior mesh prolapse surgery
Unable to tolerate General anesthetic

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 sent to urogynaecology clinic at Wesley, Royal Brisbane and Mater Hospitals in Brisbane who meet the inclusion and exclusion crieteria were offered participation.
Those that agreed were given a laymans summary of the trial and if happy were recruited in the study. Allocation to treatment was based on PC generated randomisation list that were stratiifid for Urinary stress incontinence to ensure equal representation in both treatment arms. Allocation was concealed from surgeon and participant by randomisation list held by secretary contacted by phone after the consent obtained ( central randomisation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list computer generated with seperate list for each hospital and stratified for presence of urinary stress incontinence. Statistician generated randomisation list
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4410 0
Other Collaborative groups
Name [1] 4410 0
Australian Gynaecology Endoscopy Society
Country [1] 4410 0
Australia
Primary sponsor type
Individual
Name
A Professor Christopher maher
Address
30 chasley St Auchenflower 4066
Country
Australia
Secondary sponsor category [1] 3968 0
None
Name [1] 3968 0
Address [1] 3968 0
Country [1] 3968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6457 0
Wesley hospital Ethics committee
Ethics committee address [1] 6457 0
451 Coronation Drive
Auchenflower
QLD
AUSTRALIA
4066
Ethics committee country [1] 6457 0
Australia
Date submitted for ethics approval [1] 6457 0
Approval date [1] 6457 0
Ethics approval number [1] 6457 0
2004/45

Summary
Brief summary
Purpose and Background of this research
During your last appointment in Dr Maher’s clinic you have decided to undergo an operation to correct genital prolapse with or without stress incontinence. We currently conduct the above study to compare two different approaches of prolapse repairs, the laparoscopic = “key-hole surgery” and the vaginal route. Both routes have been shown to be safe and efficient with similar success rates but they have never been compared in a randomised controlled trial. Success, complications and risks of the operations are individually different depending on previous operations for example. These issues will be discussed with you prior to the operation.

You are invited to participate in this research project because we think that your prolapse can be repaired by both routes the key-hole surgery or the vaginal repair. The results of this repair will help future patients and doctors to decide on the best management of prolapse.

3. Procedures
If you decide to take part in this study, the computer will allocate you by chance to undergo key-hole or vaginal surgery. There will be no extra tests than those required for any of the surgery. We will ask you to complete three different questionnaires regarding your symptoms and effect on your quality of life before and six months after the surgery. After surgery, we will review the outcome at a routine six-weeks, six-months and one-year appointment or more often as required.

4. Possible benefits
Participation in the study is voluntary. There are no direct benefits for you from participating. Future patients with similar problems might benefit from the study results when deciding on the most appropriate route of prolapse and stress incontinence repair.
You will not be paid for your participation in this project.

5. Possible risks
Your decision to take part or not does not in any way affect your future treatment. Participating in this study does not involve any additional risk than the surgery you had already decided to undergo for the treatment of your problems. The benefits, risks and complications of the different procedures are explained in specific surgical information sheets that will be provided to you before you decide to take part in this project. All procedures, risks and complications will be discussed with you prior to the surgery.

6. Alternative to participation
The alternative to surgery is conservative management of your prolapse with or without stress incontinence which we will have offered to you before considering surgery. If you do not feel comfortable with one or another part of the surgery, you may withdraw from the study at any time before the surgery starts without any explanation.

7. Privacy and Confidentiality
Your confidentiality is ensured by using your hospital number only. The results of this study will be published in a way that prevents any identification. The research data will be kept in a safe way for at least seven years. Only the above named researchers and a research nurse will have access to the collected data.
Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. In any publication, information will be provided in such a way that you cannot be identified.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 29213 0
Address 29213 0
Country 29213 0
Phone 29213 0
Fax 29213 0
Email 29213 0
Contact person for public queries
Name 12460 0
A Prof Christopher maher
Address 12460 0
Urogynaecologyist 30 chasley Street Auchenflower 4066 Brisbane
Country 12460 0
Australia
Phone 12460 0
+61 7 38769695
Fax 12460 0
+61 7 38711128
Email 12460 0
chrismaher@urogynaecology.com.au
Contact person for scientific queries
Name 3388 0
A prof Christopher Maher
Address 3388 0
30 chasley Street Auchenflower 4066
Brisbane
Country 3388 0
Australia
Phone 3388 0
+61 7 38767272
Fax 3388 0
+61 7 3871128
Email 3388 0
chrismaher@urogynaecology.com.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.