To compare the effects of sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure on pelvic floor function.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life related to pelvic floor function measured using validated
disease-specific quality of life questionnaires (UDI, DDI, IIQ).
Secondary outcome
Sexual function measured using the PISQ-12 questionnaire (if applicable),
POP-Q, morbidity (including post-operative pain, complications and recovery of
normal daily activities), disease specific and generic quality of life,
repeated pelvic floor surgery within 36 months after intervention and cost
analysis.
Background summary
Pelvic organ prolapse is a common health problem, with a life time risk to
undergo surgery of 11%. Many patients have a combination of different
compartments involved in the prolapse of which the most prevalent combination
is apical and anterior compartment prolapse. Sacrospinous ligament fixation
combined with anterior colporrhaphy is the most frequent proposed procedure,
but recently a mesh procedure (Elevate Anterior) was introduced that covers
both compartments in one procedure. Although mesh is not recommended as primary
procedure based on objectified adverse effects like exposure, pelvic pain and
dyspareunia, there is theoretical basis to believe that for the combination of
apical and anterior compartment prolapse, Elevate Anterior is beneficial
compared to native tissue repair. We propose a multi-center RCT comparing the
combination of sacropinous ligament fixation and anterior colporraphy to
Elevate Anterior in primary apical and anterior compartment prolapse.
Study objective
To compare the effects of sacrospinous ligament fixation combined with anterior
colporrhaphy versus Elevate Anterior procedure on pelvic floor function.
Study design
A multi-center randomised controlled trial.
Intervention
Elevate Anterior or sacrospinous ligament fixation combined with anterior
colporrhaphy
Study burden and risks
As we compare two strategies that are already applied in current clinical
practice, no additional risks from both procedures are expected. Evaluation
will take place after 6 weeks (routine post-operative consultation), by
telephone after 6 months and patients will be invited for an extra visit to the
hospital at 12, 24 and 36 months.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Women with a primary apical and anterior compartment prolapse stage >= 2 requiring surgery.
Exclusion criteria
- Previous prolapse surgery
- Enterocele stage >= 2 after hysterectomy (performed for other reasons than prolapse)
- Known malignancy
- Pregnancy or wish to become pregnant
- Unwilling to return for follow-up or language barriers
- Presence of immunological / haematological disorders interfering with recovery after surgery
- Abnormal ultrasound findings of uterus or ovaries.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38228.018.11 |
| OMON | NL-OMON25045 |