search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Avaulta versus anterior colporraphy


- candidate number3614
- NTR NumberNTR1376
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2008
- Secondary IDs06-264 MEC
- Public TitleAvaulta versus anterior colporraphy
- Scientific TitleA randomised controlled trial comparing the clinical and cost-effectiveness of the Avaulta anterior mesh and the standard anterior colporraphy for the primary surgical treatment of a cystocele stage ≥ 2
- ACRONYMAvaulta versus anterior colporraphy
- hypothesisWith usage of mesh material (Avaulta anterior) in the treatment of a cystocele >/ 2 with complaints a better anatomical result is achieved in comparence with the standard treatment (anterior colporraphy).
- Healt Condition(s) or Problem(s) studiedMesh, Anterior prolapse surgery, Cystocele
- Inclusion criteria1. Women aged 40-80 years
2. Cystocele stage 2 according to POP Q classification
3. No previous anterior colporraphy
4. Good understanding of Dutch language in word en writing
- Exclusion criteria1. Women with childbearing potential who do not use adequate contraceptive measures (hormonal contraceptives, barrier methods (condoms), intra uterine device, male vasectomy, sterilisation).
2. History of major gynaecological or urological surgery, with the exception of a hysterectomy for reasons other than a genital prolapse.
3. History of cancer or severe cardiopulmonary disease
4. Conditions that might interfere with a successful conduction and completion of the study in the opinion of the specialist (language problems, cognitive dysfunction, etc)
5. Recurrent lower urinary tract infections (> 3 culture proven infections/year)
6. Maximum bladder capacity < 300 ml (bladder diary)
7. Urinary stress incontinence with an indication for surgical correction.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-mei-2007
- planned closingdate31-dec-2010
- Target number of participants115
- InterventionsWomen are either allocated to a group who will undergo a classic anterior colporraphy repair or a group in which the Avaulta® mesh is used
- Primary outcomeThe number of women who will have a recurrence, defined as a stage 2 anterior vaginal prolapse at 2 years follow-up.
- Secondary outcome- The effect of surgery on urogenital symptoms and quality of life
- Complications of surgery (direct and medium term)
- Cost-effectiveness analysis.
- TimepointsPre-operative, 6 weeks, 3, 6,12 and 24 months postoperative
- Trial web sitehttp://www.studies-obsgyn.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Vollebregt
- CONTACT for SCIENTIFIC QUERIES A. Vollebregt
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryOBJECTIVE:
After a standard surgical anterior colporrhaphy for an anterior vaginal wall prolapse (cystocele) grade 2 or higher, one-third of women will have an anatomical recurrence within 2 years after primary surgery. The use of a non-absorbable synthetic polypropylene mesh has been shown to be effective in repeat surgery for genital prolapse, with a recurrence rate between 3-12%. However, a comparative study between the anterior colporrhaphy and surgery with a non-absorbable synthetic mesh as primary treatment for an anterior vaginal wall prolapse has not been conducted.
The objective of this study is to compare the clinical and cost-effectiveness of an anterior colporrhaphy repair with a cystocele repair using a non-absorbable synthetic Avaulta mesh.

STUDY DESIGN:
Multicentre prospective randomised controlled trial.

STUDY POPULATION:
Women 40 -80 years of age with a cystocele stage 2 or higher, according to the POPQ classification, who are scheduled for primary surgery.

INTERVENTION:
Women are either allocated to a group who will undergo a classic anterior colporraphy repair or a group in which the Avaulta mesh is used.

OUTCOME MEASURES:
The primary endpoint of the study is the number of women who will have a recurrence, defined as a stage 2 anterior vaginal prolapse at 2 years follow-up. Secundary endpoints are:
- The effect of surgery on urogenital symptoms and quality of life
- Complications of surgery (direct and medium term)
- Cost-effectiveness analysis.

POWER / DATA ANALYSIS:
Assuming that in the standard anterior colporrhaphy group 35% of women will have a recurrent cystocele stage 2 at the 2 year follow up and an estimated recurrence rate of 10% in the Avaulta anterior group , 50 women have to be assigned to each group (power 0,80, alpha 0.05). With an estimated drop-out of 15%, a total of 115 women have to be randomized.

TIME-SCHEDULE:
38 months: 12 months for inclusion, 24 months follow-up and 2 months analysis and report.

- Main changes (audit trail)
- RECORD14-jul-2008 - 23-jul-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl