CClinicalTrials.gg
CompletedNCT02059954Updated Apr 17, 2018

Vaginal vs. Laparoscopic Hysterectomy

An interventional study of Hysterectomy in Uterine Fibroids, Uterine Leiomyoma and Abnormal Uterine Bleeding, Unspecified, sponsored by Medical University of Graz. Completed at 3 sites in Austria. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Uterine Fibroids
  • Uterine Leiomyoma
  • Abnormal Uterine Bleeding, Unspecified

Keywords

  • Hysterectomy
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 100 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Vaginal hysterectomy

    Vaginal hysterectomy

    Procedure: Hysterectomy

  • Active comparator
    Total laparoscopic hysterectomy

    Laparoscopic hysterectomy

    Procedure: Hysterectomy

Interventions

  • ProcedureHysterectomy
06

What researchers measure

Primary outcomes

  1. Operating time (min.)

    Operating time (min.)

    Time frame: Surgery

Secondary outcomes

  1. Complications

    Intraoperative and postoperative complications

    Time frame: 6 weeks

  2. Anesthesia time (min.)

    Time frame: surgery

  3. Quality of life

    Time frame: 12 months

  4. Sexual health

    Time frame: 12 months

  5. Return to work

    Time frame: 3 months

07

Study locations

3 sites
  • Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
    Graz, 8020, Austria
  • Medical University of Graz/Dept. OB/GYN
    Graz, 8036, Austria
  • LKH Leoben/Abteilung Gynäkologie
    Leoben, 8700, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02059954
Lead sponsor
Medical University of Graz
Collaborators
Austrian Urogynecology Working Group (AUWG)
Responsible party
Sponsor
First posted
Feb 11, 2014
Start date
Jan 2014
Primary completion
Aug 2016
Completion
Sep 2017
Last update
Apr 17, 2018

Study contacts

Karl F Tamussino, MD
study chair · Medical University of Graz
Rene W Laky, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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