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Trial registered on ANZCTR


Registration number
ACTRN12611001111965
Ethics application status
Approved
Date submitted
22/10/2011
Date registered
25/10/2011
Date last updated
7/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Anterior Elevate or Laparoscopic Abdominal Sacrocolpopexy in women with post hysterectomy apical prolapse – a Randomised Controlled Trial
Scientific title
In patients with post hysterectomy prolapse, is Anterior Elevate mesh kit as good as or better than Laparoscopic Sacrocolpopexy for prolapse recurrence
Secondary ID [1] 273254 0
Nil
Universal Trial Number (UTN)
Trial acronym
AELAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post hysterectomy vaginal vault prolapse 279018 0
Condition category
Condition code
Renal and Urogenital 279204 279204 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anterior Elevate mesh kit

to provide support, a synthetic monofilament polypropylene mesh (permanent) is placed under the bladder and top of vagina, via a vagina incision in this operation that could take up to 1.5 hours
Intervention code [1] 269595 0
Treatment: Surgery
Intervention code [2] 269596 0
Treatment: Devices
Comparator / control treatment
Laparoscopic Sacrocolpopexy

to provide support, a synthetic monofilament polypropylene mesh (permanent) is placed under the bladder and top of vagina, via a laparoscopic (keyhole in abdomen) incision in this operation that could take up to 2.5 hours
Control group
Active

Outcomes
Primary outcome [1] 279839 0
Incidence of apical prolapse greater or equal to stage 2 (Point C below -1cm)
Timepoint [1] 279839 0
12 months & 36 months
Secondary outcome [1] 294547 0
Incidence of overall prolapse greater or equal to stage 2
Timepoint [1] 294547 0
12 months & 36 months
Secondary outcome [2] 294548 0
subjective prolapse symptom score using PFDI-20
Timepoint [2] 294548 0
12 months & 36 months
Secondary outcome [3] 294549 0
(prolapse) symptom impact using PFIQ 7
Timepoint [3] 294549 0
12 months & 36 months
Secondary outcome [4] 294550 0
global impression of improvement using PGI-I
Timepoint [4] 294550 0
12 months & 36 months
Secondary outcome [5] 294551 0
sexual function using PISQ 12
Timepoint [5] 294551 0
12 months & 36 months

Eligibility
Key inclusion criteria
1.patients with symptomatic post hysterectomy Apical Prolapse greater or equal to Stage 2 (point C greater than or equal to -1) referred for surgery
2.Willing to participate and return for follow up
3.able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Unable to undergo GA
2.Unable to understand questionnaires, give informed consent or return for review
3.BMI >35
4. more than or equal to 5 laparotomies
5. Previous synthetic mesh used for POP
6. Previous sacro colpopexy
7. total vaginal length < 6cm
8. chronic pelvic pain
9. Genito urinary anomaly (congenital)
10.Neurogenic bladder disorders
11.Previous radiation therapy to pelvis
12.Past history of any form of fistula involving the vagina
13.Allergy to polypropylene or local anaesthetic

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)
Symptomatic patients referred for surgery will be assessed and recruited from pelvic floor clinic or urodynamic clinic. Random allocation involved contacting the holder of the allocation schedule who was at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random table, stratified to centres
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284081 0
Self funded/Unfunded
Name [1] 284081 0
Country [1] 284081 0
Primary sponsor type
Individual
Name
Anna Rosamilia
Address
Suite 8, Cabrini Medical Centre Malvern
183 Wattletree Road, VIC 3144
Country
Australia
Secondary sponsor category [1] 269048 0
Individual
Name [1] 269048 0
Joseph Lee
Address [1] 269048 0
c/o Pelvic Floor Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country [1] 269048 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272039 0
Southern Health HREC
Ethics committee address [1] 272039 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 272039 0
Australia
Date submitted for ethics approval [1] 272039 0
Approval date [1] 272039 0
22/09/2011
Ethics approval number [1] 272039 0
11262B

Summary
Brief summary
Female pelvic organ prolapse, which is a protrusion of vaginal walls beyond the hymen, is both common and have a high burden of suffering. The traditional operation to treat post hysterectomy vaginal apical prolapse has been either abdominal sacrocolpopexy or vaginal sacrospinous fixation. Although the abdominal approach comes with a greater cure rate, it has a longer operating time, longer return to Activities of Daily Living and costs more than the vaginal approach. Modern advances involve the development of minimally invasive procedures which included a laparoscopic approach to abdominal sacrocolpopexy and also the introduction of vaginal mesh kits which provides better success rates when compared to the traditional vaginal operation, although not without its own sets of operative morbidity. These procedures involve inserting synthetic material anchored to the sacrospinous ligament to provide reinforcement and support to the vagina following its repair. Anterior Elevate is a new mesh kit which utilises a standard synthetic mesh using a surgical approach (anterior sacrospinous) that has been well established since 2001. The purpose of this project is to evaluate the success of Anterior Elevate vaginal mesh support or laparoscopic sacrocolpopexy in the treatment of women with vaginal apical prolapse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33297 0
Address 33297 0
Country 33297 0
Phone 33297 0
Fax 33297 0
Email 33297 0
Contact person for public queries
Name 16544 0
Alison Leitch
Address 16544 0
c/o Urodynamic Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 16544 0
Australia
Phone 16544 0
+61399288588
Fax 16544 0
+61399288338
Email 16544 0
[email protected]
Contact person for scientific queries
Name 7472 0
Joseph Lee
Address 7472 0
c/o Pelvic Floor Clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 7472 0
Australia
Phone 7472 0
+61399288588
Fax 7472 0
+61399288588
Email 7472 0
[email protected]

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.