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Vaginal vs. Laparoscopic Hysterectomy

M

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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