Vaginal vs. Laparoscopic Hysterectomy
This trial is active, not recruiting.
|Conditions||uterine fibroids, uterine leiomyoma, abnormal uterine bleeding, unspecified|
|Sponsor||Medical University of Graz|
|Collaborator||Austrian Urogynecology Working Group (AUWG)|
|Start date||January 2014|
|End date||August 2015|
|Trial size||100 participants|
|Trial identifier||NCT02059954, 26-122 ex 13/14, MUG 26-122 ex 13/14|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Graz, Austria||Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie||no longer recruiting|
|Graz, Austria||Medical University of Graz/Dept. OB/GYN||no longer recruiting|
|Leoben, Austria||LKH Leoben/Abteilung Gynäkologie||no longer recruiting|
|Intervention model||parallel assignment|
Operating time (min.)
time frame: Surgery
time frame: 6 weeks
Anesthesia time (min.)
time frame: surgery
Quality of life
time frame: 12 months
time frame: 12 months
Return to work
time frame: 3 months
Female participants from 18 years up to 80 years old.
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
|Official title||Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial|
|Principal investigator||Rene W Laky, MD|
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