|- candidate number||14825|
|- NTR Number||NTR3977|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-apr-2013|
|- Secondary IDs||ABR44799 CCMO|
|- Public Title||Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse.|
|- Scientific Title||Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse.|
|- hypothesis||Based on the literature, we expect that the laparoscopic sacrocolpopexy will be equally or more successful in correction of vault prolapse as compared to vaginal sacrospinous fixation. |
|- Healt Condition(s) or Problem(s) studied||Pelvic organ prolaps, Laparoscopy, Sacral colpopexy, Sacrospinous fixation, Vault prolapse|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
1. Symptomatic vault prolapse POP-Q grade 2 which needs surgical treatment;
2. Eligible for both surgical treatments.
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
1. Previous surgical treatment of vault prolapse;
2. Contra-indication for a surgical intervention;
3. Incapacitated patients.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2013|
|- planned closingdate||1-jul-2018|
|- Target number of participants||74|
|- Interventions||1. Laparoscopic sacrocolpopexy;|
2. Vaginal sacrospinous fixation.
|- Primary outcome||The primary outcome is disease specific quality of life during a follow-up period of one year using the Dutch validated version of the Urinary Distress Inventory (UDI).|
|- Secondary outcome||Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, post-operative recovery, procedure related morbidity, sexual function, quality of life, anatomical results using the POP-Q classification until one year follow-up, type and number of re-interventions, costs and cost-effectiveness and long term complications. |
|- Timepoints||Participants fill out questionnaires at 4 different moments, which will take them about 15 minutes at each occasion. Physical examination will be performed pre-operative, six weeks post-operative and the last examination will be done after one year.|
|- Trial web site||www.studies-obsgyn.nl/salto|
|- CONTACT FOR PUBLIC QUERIES|| A.L.W.M. Coolen|
|- CONTACT for SCIENTIFIC QUERIES|| A.L.W.M. Coolen|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center|
|- Brief summary||Rationale/Objective: |
It has been estimated that one in nine women will undergo a hysterectomy during lifetime. Up to 10% of the women who had a hysterectomy because of prolapse symptoms, will subsequently need surgical repair for vaginal vault prolapse thereafter. A variety of different surgical procedures to correct vaginal vault prolapse have been reported1. The reconstructive techniques can principally be divided into vaginal or abdominal procedures.
No prospective comparative studies of VSF and LSC are performed. Literature shows that abdominal sacrocolpopexy is better than vaginal sacrospinous fixation in terms of a lower recurrence and dyspareunia rate although operation time and hospital stay is longer. However hospital stay in laparoscopic sacrocolpopexy is shorter compared to the abdominal technique. This suggests that laparoscopic sacrocolpopexy might be a preferable treatment option for a vaginal vault prolapse. However, prospective trials comparing VSF and LSC are lacking. The aim of this randomized study is to compare the short- and long-term outcome of the VSF and LSC5,6,10.
Multicentre prospective randomized controlled trial.
Women with a posthysterectomy symptomatic vaginal vault prolapse.
Random allocation to vaginal sacrospinous fixation or laparoscopic sacrocolpopexy.
Main study parameters/endpoints:
Primary outcome is disease specific quality of life during a follow-up period of one year. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification until one year follow-up, type and number of re-interventions, costs and cost-effectiveness.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As this study compares two common treatment regimens, it will not impose extra risk on the participants. Participants fill out questionnaires at 4 different moments, which will take them about 15 minutes at each occasion. Physical examination will be performed pre-operative, six weeks post-operative and the last examination will be done after one year.
|- Main changes (audit trail)|
|- RECORD||28-apr-2013 - 14-mei-2013|