To investigate the hypothesis that women with uterine prolapse stage 2 or more treated by sacrospinous fixation have equal or lower recurrence rate of prolapse than women with a vaginal hysterectomy.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: anatomical outcome and recurrence rate assessed by a
POP-Q-test.
Secondary outcome
Secondary outcomes are subjective improvement on urogenital symptoms and
quality of life (assessed by disease-specific and quality of life
questionnaires), complications following surgery, hospital stay, post-operative
recovery, sexual functioning and costs.
Background summary
Uterovaginal prolapse is a common health problem, affecting up to 40% of parous
women over 50 years old, with significant influence on quality of life. In the
Netherlands vaginal hysterectomy is currently the leading treatment method for
patients with symptomatic uterovaginal prolapse. Several studies have shown
that sacrospinous fixation in case of uterine or vaginal vault prolapse is a
safe and effective alternative to vaginal hysterectomy. However to date no
large randomised trials with long-term follow-up have been performed to compare
efficacy and quality of life between both techniques.
Study objective
To investigate the hypothesis that women with uterine prolapse stage 2 or more
treated by sacrospinous fixation have equal or lower recurrence rate of
prolapse than women with a vaginal hysterectomy.
Study design
A multi-center, prospective, randomised, non-blinded clinical trial. Evaluation
will take place in every center pre-operatively, after 6 weeks, 6 months, 12
months and annually thereafter.
Intervention
Random allocation to sacrospinous fixation or vaginal hysterectomy
Study burden and risks
As we compare two strategies that are already applied in current practice, no
additional risks from both procedures are expected. During follow up extra
visits to the hospital for gynaecological examination and data obtaining
(self-reported questionnaires) will be necessary in both groups.
Postbus 10400
8000 GK Zwolle
NL
Postbus 10400
8000 GK Zwolle
NL
Listed location countries
Age
Inclusion criteria
POP-Q stage >=2 uterine descent requiring surgery. Patients with co-existing anterior/ posterior defects or concomitant incontinence surgery (TVT-O) can be included
Exclusion criteria
- Previous pelvic floor or prolapse surgery
- Known malignancy or abnormal cervical smears
- Wish to preserve fertility
- 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, or abnormal uterine bleeding.
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 | NL28669.075.09 |