Abnormal Uterine Bleeding, Unspecified, Uterine Fibroids, Uterine Leiomyoma
Conditions
Keywords
Hysterectomy
Brief summary
Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing. This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.
Interventions
PROCEDUREHysterectomy
Sponsors
Austrian Urogynecology Working Group (AUWG)
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia) * clinical exam indicates vaginal hysterectomy is feasible * no major concomitant surgery * able to complete questionnaires in German
Exclusion criteria
* uterine malignancy * major concomitant surgery (e.g., for incontinence or prolapse) * clinical exam indicating vaginal hysterectomy not feasible * contraindication for surgery or laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating time (min.) | Surgery | Operating time (min.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 6 weeks | Intraoperative and postoperative complications |
| Anesthesia time (min.) | surgery | — |
| Quality of life | 12 months | — |
| Sexual health | 12 months | — |
| Return to work | 3 months | — |
Countries
Austria
Outcome results
None listed