Laparoscopic Technique no Switch to OpenNCT00683293
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
A study testing Conventional Laparoscopic Hysterectomy and Robot-assisted (Da Vinci®) laparoscopic hysterectomy in people with Laparoscopic Technique no Switch to Open and Duration of Surgery, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications
- What is being tested?
- Conventional Laparoscopic Hysterectomy and Robot-assisted (Da Vinci®) laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for laparoscopic hysterectomy
- Patients BMI < 40
- Signed consent
Who cannot join
- Estimated uterus weight >400 g
- No combination with other procedures
- No underlying malignant condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.
Read the detailed description
During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.
Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.
- Conditions
- Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications, Postoperative Complications
- Being tested
- Conventional Laparoscopic Hysterectomy, Robot-assisted (Da Vinci®) laparoscopic hysterectomy
- Keywords
- Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery
- Medical subject headings
- Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Laparoscopic HysterectomyProcedure or surgery
Also called - Minimal invasive hysterectomy,, - Laparoscopic removal of uterus,, - Minimal invasive removal of uterus
Removal of uterus via standard laparoscopic techniques
Robot-assisted (Da Vinci®) laparoscopic hysterectomyProcedure or surgery
Also called - Robot-assisted(Da Vinci®)laparoscopic hysterectomy, - Robot-assisted minimal invasive hysterectomy
Removal of uterus by robot-assisted laparoscopic technique
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Randomized group of patients receiving conventional laparoscopic hysterectomy Receives: Procedure: Conventional Laparoscopic Hysterectomy |
| 2 | Active comparator | Randomized group of patients receiving robot-assisted laparoscopic hysterectomy Receives: Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Surgery
•Mean Time to complete surgery from cut to suture
Measured: after surgey
Secondary outcomes (1)
Complications
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Technique no Switch to OpenStudies 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
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Sarlos, Kantonsspital Aarau
- Investigators
- Dimitri Sarlos, MD, Study chair, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683293
- Sponsor's protocol ID
- KSA-RobHyst
- Status last verified
- Mar 2014
- First submitted
- 21 May 2008
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
PubMed 22914470
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
- ClinicalTrials.gov ID
- NCT00683293
- Acronym / sponsor ID
- KSA-RobHyst
- Conditions
- Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications, Postoperative Complications
- Keywords
- Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 16 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.
Detailed description
During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.
Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Conventional Laparoscopic HysterectomyRandomized group of patients receiving conventional laparoscopic hysterectomy |
| 2 | Active comparator | Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomyRandomized group of patients receiving robot-assisted laparoscopic hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for laparoscopic hysterectomy
- Patients BMI < 40
- Signed consent
Key exclusion criteria (3 listed)
- Estimated uterus weight >400 g
- No combination with other procedures
- No underlying malignant condition
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 |
|---|---|---|
| Conventional Laparoscopic HysterectomyAlso: - Minimal invasive hysterectomy,, - Laparoscopic removal of uterus,, - Minimal invasive removal of uterusRemoval of uterus via standard laparoscopic techniques | Procedure or surgery | 1 |
| Robot-assisted (Da Vinci®) laparoscopic hysterectomyAlso: - Robot-assisted(Da Vinci®)laparoscopic hysterectomy, - Robot-assisted minimal invasive hysterectomyRemoval of uterus by robot-assisted laparoscopic technique | Procedure or surgery | 2 |
Primary outcome
Duration of Surgery
Time frame: after surgey
•Mean Time to complete surgery from cut to suture
1 secondary outcome
Complications
Time frame: up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22914470Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
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.
Dimitri Sarlos, MD study chair
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Laparoscopic Hysterectomy and Robot-assisted (Da Vinci®) laparoscopic hysterectomy in people with Laparoscopic Technique no Switch to Open and Duration of Surgery, run by Kantonsspital Aarau at 1 site in Switzerland.
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 3 inclusion and 3 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 16 Apr 2014. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Surgery (time frame: after surgey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683293, which also lists 1 linked publication.
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 16 Apr 2014.