To evaluate long-term outcome (3-10 years) in terms of quality of life, subjective and anatomic failure and erosion after laparoscopic versus open abdominal sacrocolpopexy as a treatment for vaginal vault prolapse in patients with a history of…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the long-term disease specific quality of
life, measured using the Dutch validated version of the Urinary Distress
Inventory.
Secondary outcome
Secondary outcomes will be patient*s subjective satisfaction, general quality
of life, sexual functioning, subjective recurrence, objective recurrence using
the POP-Q classification, type and number of re-interventions and complications
on the long term.
Background summary
It has been estimated that one in nine women will undergo a hysterectomy during
life. Up to 10% of these women will subsequently need surgical repair for
vaginal vault prolapse. Sacrocolpopexy is a generally applied treatment, which
can be performed by laparoscopy or by laparotomy. After the laparoscopic
abdominal sacrocolpopexy had been reported, this procedure has gained
popularity. We performed a randomised controlled trial (RCT) comparing
laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy, with disease
specific quality of life after 1 year as primary outcome (SALTO-1 trial, METC
0631, registered as NTR3276). Results have recently been submitted for
publication. Studies to evaluate long-term outcome in this patient group are
essential for giving consensus regarding optimal surgical treatment. We
therefore propose a long-term follow-up of the SALTO-1 study.
Study objective
To evaluate long-term outcome (3-10 years) in terms of quality of life,
subjective and anatomic failure and erosion after laparoscopic versus open
abdominal sacrocolpopexy as a treatment for vaginal vault prolapse in patients
with a history of hysterectomy.
Study design
Long-term follow-up of a multicentre RCT.
Study burden and risks
Participation in the study entails a one-time questionnaire containing UDI,
DDI, IIQ, PIS-Q, PFDI-20 and SF-36, which will take approximately 20 minutes
and secondly a single visit to the outpatient clinic of the nearest
participating hospital for a gynecological examination using the POP-Q
classification. Subjects will not be at any risk of complications during this
study. The POP-Q is a non-invasive, safe way to objectify pelvic floor
problems. Subjects can however experience some discomfort during the exam.
Though this study will not benefit the participators directly, it will increase
our knowledge of long-term outcome after laparoscopic versus open abdominal
sacrocolpopexy, which is needed to give consensus regarding optimal surgical
treatment for vaginal vault prolapse in patients with a history of
hysterectomy.
De Run 4600
Veldhoven 5500 MB
NL
De Run 4600
Veldhoven 5500 MB
NL
Listed location countries
Age
Inclusion criteria
- All patients from the original SALTO trial.
- Willing to participate.
Exclusion criteria
- Deceased patients
- Unwilling to participate.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60618.015.17 |
| Other | NTR26500 |