Endometrium CancerNCT01466777
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
A study testing Traditional surgery type and Robotic assisted laparoscopic surgery in people with Endometrium Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients. The study is prospective and the patients are randomised into two groups of 50 patients each. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- Traditional surgery type and Robotic assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2010to Sep 2019
- 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 30 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
- Gr 1 and 2 differentiation type
Who cannot join
- The operation cannot be made with an laparoscopy operation
- Age more than 85 years or young under 30 years patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.
The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.
The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.
Secondary endpoints include:
- bleeding
- complications
- conversions
- number of pelvic lymph nodes
- Conditions
- Endometrium Cancer
- Being tested
- Traditional surgery type, Robotic assisted laparoscopic surgery
- Keywords
- Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications, Conversions, Pelvic lymph node
- Medical subject headings
- Endometrial Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional surgery typeProcedure or surgery
Traditional laparoscopic surgery for endometrial cancer
Robotic assisted laparoscopic surgeryProcedure or surgery
Robotic assisted laparoscopic surgery for endometrial cancer
| Study group | Role | What they receive |
|---|---|---|
| traditional laparoscopic surgery type | Active comparator | Not described Receives: Procedure: Traditional surgery type |
| Robotic assisted operation type | Experimental | Not described Receives: Procedure: Robotic assisted laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the operation time
Measured: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary outcomes (4)
bleeding
Measured: Duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events
Measured: Duration of hospital stay, an expected average of 5 weeks
Pain
visual analogue scale
Measured: Duration of hospital stay, an expected average of 5 weeks
pelvic lymph node volumes
Measured: Duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrium CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minna Mäenpää, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466777
- Sponsor's protocol ID
- R10081
- Status last verified
- Jun 2019
- First submitted
- 18 Aug 2011
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073.
PubMed 28937446
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT01466777
- Acronym / sponsor ID
- R10081
- Conditions
- Endometrium Cancer
- Keywords
- Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Nov 2011 (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.
The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.
The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.
The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.
Secondary endpoints include:
- bleeding
- complications
- conversions
- number of pelvic lymph nodes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional laparoscopic surgery type | Active comparator | Procedure: Traditional surgery type |
| Robotic assisted operation type | Experimental | Procedure: Robotic assisted laparoscopic surgery |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
- Gr 1 and 2 differentiation type
Key exclusion criteria (2 listed)
- The operation cannot be made with an laparoscopy operation
- Age more than 85 years or young under 30 years patient
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 |
|---|---|---|
| Traditional surgery typeTraditional laparoscopic surgery for endometrial cancer | Procedure or surgery | traditional laparoscopic surgery type |
| Robotic assisted laparoscopic surgeryRobotic assisted laparoscopic surgery for endometrial cancer | Procedure or surgery | Robotic assisted operation type |
Primary outcome
the operation time
Time frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
4 secondary outcomes
bleeding
Time frame: Duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events
Time frame: Duration of hospital stay, an expected average of 5 weeks
Pain
Time frame: Duration of hospital stay, an expected average of 5 weeks
pelvic lymph node volumes
Time frame: Duration of hospital stay, an expected average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 28937446Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional surgery type and Robotic assisted laparoscopic surgery in people with Endometrium Cancer, run by Tampere University Hospital at 1 site in Finland.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2019. 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 Finland. 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?
Results are not available in the source record.
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?
the operation time (time frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours). 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 NCT01466777, 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 6 Jun 2019.