Vaginal vs. Laparoscopic Hysterectomy

Medical University of Graz

Status: Completed

Conditions: Uterine Leiomyoma; Uterine Fibroids; Abnormal Uterine Bleeding, Unspecified

Treatments: Procedure: Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02059954

MUG 26-122 ex 13/14 (Other Identifier)

26-122 ex 13/14

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Vaginal hysterectomy

Active Comparator group

Description:

Vaginal hysterectomy

Treatment:

Procedure: Hysterectomy

Total laparoscopic hysterectomy

Active Comparator group

Description:

Laparoscopic hysterectomy

Treatment:

Procedure: Hysterectomy