No registrations found.
ID
Source
Brief title
Health condition
- uterine descent, vaginal hysterectomy, sacrospinous fixation
- descensus uteri, vaginale hysterectomie,
sacrospinale fixatie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Surgical failure, defined as recurrence of prolapse POP-Q stage 2 of the middle compartment and prolapse complaints and/or redo surgery.
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 and sexual functioning.
Background summary
Randomized controlled trial to study the effects of sacrospinous fixation versus vaginal hysterectomy, on prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery, sexual functioning and costs.
Study objective
In the treatment of a uterine prolapse stage 2 or higher sacrospinous fixation will result in equal or lower recurrence rate of prolapse than a vaginal hysterectomy.
Study design
Pre-operative, 6 weeks, 6, 12, 24, 36, 48 and 60 months postoperative.
Intervention
Random allocation to sacrospinous fixation or vaginal hysterectomy.
R.J. Detollenaere
Isala Klinieken afdeling Obstetrie en gynaecologie
Zwolle 8000 GK
The Netherlands
+31 (0)38 424 7415
r.j.detollenaere@isala.nl
R.J. Detollenaere
Isala Klinieken afdeling Obstetrie en gynaecologie
Zwolle 8000 GK
The Netherlands
+31 (0)38 424 7415
r.j.detollenaere@isala.nl
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
too.
Exclusion criteria
1. Previous pelvic floor or prolapse surgery;
2. Known malignancy or abnormal cervical smears;
3. Wish to preserve fertility;
4. Unwilling to return for follow-up or language barriers;
5. Presence of immunological / haematological disorders interfering with recovery after surgery;
6. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL1755 |
| NTR-old | NTR1866 |
| Other | METC Zwolle : METC 09.0652 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |