Uterine Fibroids Clinical Trial
Official title:
Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
Verified date | April 2018 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie | Graz | |
Austria | Medical University of Graz/Dept. OB/GYN | Graz | |
Austria | LKH Leoben/Abteilung Gynäkologie | Leoben |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz | Austrian Urogynecology Working Group (AUWG) |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operating time (min.) | Operating time (min.) | Surgery | |
Secondary | Complications | Intraoperative and postoperative complications | 6 weeks | |
Secondary | Anesthesia time (min.) | surgery | ||
Secondary | Quality of life | 12 months | ||
Secondary | Sexual health | 12 months | ||
Secondary | Return to work | 3 months |
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