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)


Laparoscopic sacrocolpopexy using bone anchor fixation in cases of vaginal vault prolapse.


- candidate number9324
- NTR NumberNTR2849
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2011
- Secondary IDs20004/57 TWOR Protocol
- Public TitleLaparoscopic sacrocolpopexy using bone anchor fixation in cases of vaginal vault prolapse.
- Scientific TitleLaparoscopic sacrocolpopexy using bone anchor fixation in cases of vaginal vault prolapse.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedProlapse, Incontinence
- Inclusion criteriaPatients with vaginal vault prolapse after a previous hysterectomy.
- Exclusion criteria1. Preceding rectosigmoid resection;
2. Extensive intraabdominal and/or pelvic adhesions.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-jan-2005
- planned closingdate30-jun-2011
- Target number of participants50
- InterventionsLaparoscopic sacrocolpopexy with use of titanium bone anchor and polypropylene mesh.
- Primary outcomeSuccesfull reduction of prolaps:
1. Anatomically, classification with POP-Q system;
2. In terms of patient satisfaction with validated questionnaires (Urogenital Distress Inventory (UDI), Incontinence Impact Questionnaire (IIQ) and the Defecatory Distress Inventory (DDI))11.
- Secondary outcomeUrodynamic parameters and lower urinary tract symptoms.
- Timepoints1. A minimal follow up of 6 months;
2. Urodynamic evaluation scheduled 3-6 months after surgery.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. R.M.F. Weiden, van der
- CONTACT for SCIENTIFIC QUERIESMD. PhD. R.M.F. Weiden, van der
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG)
- Funding
(Source(s) of Monetary or Material Support)
Sint Franciscus Gasthuis (SFG), Rotterdam
- PublicationsVan der Weiden RMF, Withagen MIJ, Bergkamp ABM, Mannaerts GHH. A new device for bone anchor fixation in laparoscopic sacrocolpopexy. The Franciscan laparoscic bone anchor inserter. Surg Endosc 2005; 19: 594-597.
- Brief summaryApplication of the laparoscopic bone anchor inserter in laparoscopic sacrocolpopexy is an easy and safe procedure that provides firm fixation and excellent anatomical results. The present observational study adresses long term results and patient satisfaction and includes sequential urodynamic assessment.
- Main changes (audit trail)
- RECORD11-apr-2011 - 20-apr-2011


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