Uterine FibroidsNCT02059954
Vaginal vs. Laparoscopic Hysterectomy
A study testing Hysterectomy in people with Uterine Fibroids and Uterine Leiomyoma, run by Medical University of Graz at 3 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Fibroids, Uterine Leiomyoma, Abnormal Uterine Bleeding, Unspecified
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesAustria
- Study dates
- Jan 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- uterine malignancy
- major concomitant surgery (e.g., for incontinence or prolapse)
- clinical exam indicating vaginal hysterectomy not feasible
- contraindication for surgery or laparoscopy
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
Graz, 8020
Medical University of Graz/Dept. OB/GYN
Graz, 8036
LKH Leoben/Abteilung Gynäkologie
Leoben, 8700
About this study
Official title: Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
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.
- Being tested
- Hysterectomy
- Keywords
- Hysterectomy
- Medical subject headings
- Leiomyoma, Myofibroma, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vaginal hysterectomy | Active comparator | Vaginal hysterectomy Receives: Procedure: Hysterectomy |
| Total laparoscopic hysterectomy | Active comparator | Laparoscopic hysterectomy Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time (min.)
Operating time (min.)
Measured: Surgery
Secondary outcomes (5)
Complications
Intraoperative and postoperative complications
Measured: 6 weeks
Anesthesia time (min.)
Measured: surgery
Quality of life
Measured: 12 months
Sexual health
Measured: 12 months
Return to work
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Urogynecology Working Group (AUWG)
- Responsible party
- Sponsor
- Investigators
- Karl F Tamussino, MD, Study chair, Medical University of GrazRene W Laky, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059954
- Sponsor's protocol ID
- 26-122 ex 13/14
- Other IDs
- MUG 26-122 ex 13/14
- Status last verified
- Apr 2018
- First submitted
- 10 Feb 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02059954
- Acronym / sponsor ID
- 26-122 ex 13/14
- Keywords
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Austrian Urogynecology Working Group (AUWG)
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal hysterectomy | Active comparator | Procedure: HysterectomyVaginal hysterectomy |
| Total laparoscopic hysterectomy | Active comparator | Procedure: HysterectomyLaparoscopic hysterectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- uterine malignancy
- major concomitant surgery (e.g., for incontinence or prolapse)
- clinical exam indicating vaginal hysterectomy not feasible
- contraindication for surgery or laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterectomy | Procedure or surgery | Total laparoscopic hysterectomy, Vaginal hysterectomy |
Primary outcome
Operating time (min.)
Time frame: Surgery
Operating time (min.)
5 secondary outcomes
Complications
Time frame: 6 weeks
Anesthesia time (min.)
Time frame: surgery
Quality of life
Time frame: 12 months
Sexual health
Time frame: 12 months
Return to work
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl F Tamussino, MD study chair
Medical University of Graz
Rene W Laky, MD principal investigator
Medical University of Graz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy in people with Uterine Fibroids and Uterine Leiomyoma, run by Medical University of Graz at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating time (min.) (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.