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Laparoscopic sacrocolpopexy versus open abdominal sacrocolpopexy for vaginal vault prolapse: A long term follow-up on quality of life and anatomical result


- candidate number26500
- NTR NumberNTR6330
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2017
- Secondary IDsABR  60618
- Public TitleLaparoscopic sacrocolpopexy versus open abdominal sacrocolpopexy for vaginal vault prolapse: A long term follow-up on quality of life and anatomical result
- Scientific TitleLaparoscopic sacrocolpopexy versus open abdominal sacrocolpopexy for vaginal vault prolapse: A long term follow-up on quality of life and anatomical result
- ACRONYMSALTO: Long term follow-up
- hypothesisBased on our primary results we do not expect anatomical difference between the two groups. However, we expect to see more erosion as compared to 1 year of follow-up.
- Healt Condition(s) or Problem(s) studiedSacral colpopexy, Prolapse
- Inclusion criteria- All patients from the original SALTO trial.
- Willing to participate
- Exclusion criteria- Died patients
- Unwilling to participate.
- Unable to visit the outpatient clinic.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate30-jun-2017
- Target number of participants74
- InterventionsSince this is a follow-up study, no interventions will be done. Patiente are asked to fill out a questionnaire and to come to the out patient clinic once for a physical examination using POP-Q classification.
- Primary outcomeThe primary objective of this follow-up study is to evaluate long term outcome in terms of disease specific quality of life of the patient population of the SALTO1 trial.
- Secondary outcomeThe secondary objective of this follow-up study is to evaluate long term outcome in terms of patientís subjective satisfaction, general quality of life, sexual functioning, subjective and objective recurrence, type and number of re-interventions and mesh and suture erosion in the patient population of the SALTO1 trial.
- Timepoints3-10 years postoperative:
- Questionnaire
- Physical examination using POP-Q classification
- Trial web sitewww.studies-obsgyn.nl/salto
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Marlies Bongers
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator Maxima Medisch Centrum Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- PublicationsCoolen A-LWM, van Oudheusden AMJ, Bongers MY, et al. A Comparison of Complications between Open Abdominal Sacrocolpopexy and Laparoscopic Sacrocolpopexy for the Treatment of Vault Prolapse. Obstetrics and Gynecology International. 2013;2013:528636. doi:10.1155/2013/528636.
- Brief summarySALTO: long term follow-up is a follow-up trial of the SALTO study. Primary outcome is disease specific quality of life. Secondary outcome is patientís subjective satisfaction, general quality of life, sexual functioning, subjective and objective recurrence, type and number of re-interventions and mesh and suture erosion.
- Main changes (audit trail)
- RECORD18-jan-2017 - 28-mei-2017


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