Renal CancerNCT04388917
Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?
An observational study of Renal Cancer and Kidney Cancer, run by Centre Hospitalier Universitaire de Nice.
Trial summary
One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Kidney Cancer, Blood Loss
- What is being tested?
- Patial nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients who underwent Robot Assisted Partial Nephrectomy
Who may be able to join
- all consecutive patients who underwent Robot Assisted Partial Nephrectomy
Who cannot join
- patient off clamping or partial clamping
About this study
One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. In this study, we determined whether the use of hemostatic clips during the tumor resection step reduced blood loss during robot-assisted partial nephrectomy. Methods: In this retrospective study, we included all consecutive patients who underwent RAPN in our university hospital from 2017 to 2019. Three experienced surgeons performed the surgery. One surgeon used Hemo-lock hemostatic clips during tumor resection to prevent bleeding, and two did not. Blood loss in the two groups was compared as the primary endpoint. The duration of clamping, operative time, complications, surgical margins, transfusions, serum creatinine and hemoglobin were compared as secondary endpoints. Results: 53 patients were included, 36 in the No-clip group and 17 in the Clip group. Our two groups were comparable for age, weight, Charlson score, tumor size and RENAL score. There was a significant difference between the two groups for median blood loss 50 mL in the Clip group versus 300 mL in the No-clip group (p = 0.0001), whereas median operating time was shorter in the No-clip group, 140 min versus 180 min for the Clip group (p = 0.044). No other criterion showed a significant difference. The use of Hemo-lock during the tumor resection step in RAPN reduced blood loss without impairing renal function. Larger studies are still needed to confirm our findings.
- Conditions
- Renal Cancer, Kidney Cancer, Blood Loss
- Being tested
- Patial nephrectomy
- Keywords
- robot assisted partial nephrectomy, tips
- Medical subject headings
- Kidney Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patial nephrectomyProcedure or surgery
Partial nephrectomy assisted with robot to remove kidney cancer
| Study group | Role | What they receive |
|---|---|---|
| Clip Group | Use of Hemo-lock hemostatic clips during tumor resection to prevent bleeding Receives: Procedure: Patial nephrectomy | |
| No Clip group | No Hemo-lock hemostatic clips used during tumor resection Receives: Procedure: Patial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss in the two groups was compared
It was mesured during the surgery by amount of blood drawn
Measured: 3 years
Secondary outcomes (3)
operative time
duration from the begining to the end of the surgery
Measured: 3 years
duration of clamping
time between the clips set and remove during the surgery for patient of clip group
Measured: 3 years
incidence of complications
rate of complication after surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388917
- Sponsor's protocol ID
- 20Urobase02
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan has been established
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?
- ClinicalTrials.gov ID
- NCT04388917
- Acronym / sponsor ID
- 20Urobase02
- Conditions
- Renal Cancer, Kidney Cancer, Blood Loss
- Keywords
- robot assisted partial nephrectomy, tips
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 May 2020 (actual)
- 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.
One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. In this study, we determined whether the use of hemostatic clips during the tumor resection step reduced blood loss during robot-assisted partial nephrectomy. Methods: In this retrospective study, we included all consecutive patients who underwent RAPN in our university hospital from 2017 to 2019. Three experienced surgeons performed the surgery. One surgeon used Hemo-lock hemostatic clips during tumor resection to prevent bleeding, and two did not. Blood loss in the two groups was compared as the primary endpoint. The duration of clamping, operative time, complications, surgical margins, transfusions, serum creatinine and hemoglobin were compared as secondary endpoints. Results: 53 patients were included, 36 in the No-clip group and 17 in the Clip group. Our two groups were comparable for age, weight, Charlson score, tumor size and RENAL score. There was a significant difference between the two groups for median blood loss 50 mL in the Clip group versus 300 mL in the No-clip group (p = 0.0001), whereas median operating time was shorter in the No-clip group, 140 min versus 180 min for the Clip group (p = 0.044). No other criterion showed a significant difference. The use of Hemo-lock during the tumor resection step in RAPN reduced blood loss without impairing renal function. Larger studies are still needed to confirm our findings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clip Group | – | Procedure: Patial nephrectomyUse of Hemo-lock hemostatic clips during tumor resection to prevent bleeding |
| No Clip group | – | Procedure: Patial nephrectomyNo Hemo-lock hemostatic clips used during tumor resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients who underwent Robot Assisted Partial Nephrectomy
Key inclusion criteria (1 listed)
- all consecutive patients who underwent Robot Assisted Partial Nephrectomy
Key exclusion criteria (1 listed)
- patient off clamping or partial clamping
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 |
|---|---|---|
| Patial nephrectomyPartial nephrectomy assisted with robot to remove kidney cancer | Procedure or surgery | Clip Group, No Clip group |
Primary outcome
Blood loss in the two groups was compared
Time frame: 3 years
It was mesured during the surgery by amount of blood drawn
3 secondary outcomes
operative time
Time frame: 3 years
duration of clamping
Time frame: 3 years
incidence of complications
Time frame: 3 years
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 14 May 2020.
- Individual participant dataSharing planned: No. no data sharing plan has been established
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer and Kidney Cancer, run by Centre Hospitalier Universitaire de Nice.
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 1 inclusion and 1 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood loss in the two groups was compared (time frame: 3 years). 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 14 May 2020.