MenorrhagiaNCT01865929
Minimally Invasive Benign Hysterectomy
A study testing Robotic hysterectomy and Vaginal or laparoscopic hysterectomy in people with Menorrhagia and Metrorrhagia, run by Region Skane at 1 site in Sweden.
Trial summary
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Menorrhagia, Metrorrhagia, Uterine Fibroids
- What is being tested?
- Robotic hysterectomy and Vaginal or laparoscopic hysterectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Jun 2013
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- size of uterus and vagina allows for retrieval by the vaginal route
- maximum uterine size equivalent to 16 weeks of pregnancy
- informed consent
Who cannot join
- malignant disease
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopic surgery
- women with pacemaker or other implants where electrosurgery is to be avoided
- immunoincompetent women
- simultaneous need for prolapse surgery
Show all 9Show fewer
- women with known defects of the hemostasis
- allergies towards metronidazole and doxycycline
- inability to understand patient information
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Obstetrics and Gynecology, Skane University Hospital
Lund, 221 85
About this study
Official title: Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.
Read the detailed description
Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.
Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.
- Conditions
- Menorrhagia, Metrorrhagia, Uterine Fibroids, Cervical Dysplasia
- Being tested
- Robotic hysterectomy, Vaginal or laparoscopic hysterectomy
- Medical subject headings
- Menorrhagia, Metrorrhagia, Leiomyoma, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic hysterectomyDevice
Also called da Vinci Surgical system, Intuitive Surgical Inc, CA, USA
Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy
Vaginal or laparoscopic hysterectomyProcedure or surgery
Benign hysterectomy performed by traditional minimal invasive procedures.
| Study group | Role | What they receive |
|---|---|---|
| Robotic hysterectomy | Active comparator | Minimally invasive hysterectomy by robotic surgery Receives: Procedure: Vaginal or laparoscopic hysterectomy |
| Vaginal or laparoscopic hysterectomy | Active comparator | Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery. Receives: Device: Robotic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of surgery
The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.
Measured: 4 months
Secondary outcomes (1)
Patient outcome
The number of patients in whom an intraoperative or postoperative complication occurs as well as the seriousness of the complication which occurs and what this entails for the patient in question. This includes conversions to open surgery as well as the need for reoperation and readmission.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Persson, MD, PhD, Study director, Department of Obstetrics and Gynecology, Skane University Hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865929
- Sponsor's protocol ID
- LundKK
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2013
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01865929
- Acronym / sponsor ID
- LundKK
- Conditions
- Menorrhagia, Metrorrhagia, Uterine Fibroids, Cervical Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 May 2013 (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.
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.
Detailed description
Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.
Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic hysterectomy | Active comparator | Procedure: Vaginal or laparoscopic hysterectomyMinimally invasive hysterectomy by robotic surgery |
| Vaginal or laparoscopic hysterectomy | Active comparator | Device: Robotic hysterectomyMinimal invasive hysterectomy by vaginal or traditional laparoscopic surgery. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- size of uterus and vagina allows for retrieval by the vaginal route
- maximum uterine size equivalent to 16 weeks of pregnancy
- informed consent
Key exclusion criteria (9 listed)
- malignant disease
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopic surgery
- women with pacemaker or other implants where electrosurgery is to be avoided
- immunoincompetent women
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 |
|---|---|---|
| Robotic hysterectomyAlso: da Vinci Surgical system, Intuitive Surgical Inc, CA, USAMinimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy | Device | Vaginal or laparoscopic hysterectomy |
| Vaginal or laparoscopic hysterectomyBenign hysterectomy performed by traditional minimal invasive procedures. | Procedure or surgery | Robotic hysterectomy |
Primary outcome
Cost of surgery
Time frame: 4 months
The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.
1 secondary outcome
Patient outcome
Time frame: 4 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 4 Mar 2024.
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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.
Jan Persson, MD, PhD study director
Department of Obstetrics and Gynecology, Skane University Hospital, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic hysterectomy and Vaginal or laparoscopic hysterectomy in people with Menorrhagia and Metrorrhagia, run by Region Skane at 1 site in Sweden.
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 9 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Cost of surgery (time frame: 4 months). 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 4 Mar 2024.