uterine prolapse, vaginal sacrospinous hysteropexy, laparoscopic sacrohysteropexy
Conditions
Interventions
The LAVA-trial compares the vaginal sacrospinous hysteropexy to the laparoscopic sacrohysteropexy in the treatment of uterine descent. In the vaginal sacrospinous hysteropexy, the uterus is suspended
Sponsors
Isala Klinieken Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: Women with uterine prolapse stage ≥ 2 requiring surgical treatment
Exclusion criteria
Exclusion criteria: 1. Contraindications of laparoscopic surgery; 2. Previous pelvic floor or prolapse surgery; 3. Known malignancy or abnormal cervical smears; 4. Unwilling to return for follow-up or language barriers; 5. Wish to preserve fertility; 6. Presence of immunological/haematological disorders interfering with recovery after surgery; 7. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite primary study outcome of this study is surgical success at 1 and 5 years follow-up. Surgical success is defined as 1) position of the cervix at or above the mid-vagina (C < -TVL/2), 2) no bothersome bulging/protrusion symptoms and 3) no repeat surgery or pessary use for recurrent apical prolapse. Failure in one or more of these three areas constitute a failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-effectiveness. | — |
Contacts
Public ContactM.N. IJsselmuiden, van
Isala Klinieken Zwolle, Afd. Obstetrie en Gynaecologie Postbus 10400
Outcome results
None listed