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Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse

Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse - SALTO-2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47730
Enrollment
106
Registered
2013-07-17
Start date
2013-07-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vrouwelijke geslachtsorganen: bekkenbodem Pelvic organ prolapse

Interventions

Vaginal sacrospinous fixation The right sacrospinous ligament will be selected for fixation to allow better accessibility for the right-handed surgeon. The sacrospinous ligament will be approached t

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Symptomatic vault prolapse POP-Q grade 2 which needs surgical treatment - Eligible for both surgical treatments - Patients must be able to read Dutch

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Previous surgical treatment of vault prolapse - Contra-indication for a surgical intervention - Incapacitated patients

Design outcomes

Primary

MeasureTime frame
The primary outcome is disease specific quality of life at one year follow-up using the Dutch validated version of the Urinary Distress Inventory (UDI).

Secondary

MeasureTime frame
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 at one and five years follow-up, type and number of re-interventions, costs and cost-effectiveness and long term complications.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)