Cancer of KidneyNCT05732857
Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy
A study testing valveless trocar and standard trocar in people with Cancer of Kidney, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Kidney
- What is being tested?
- valveless trocar and standard trocar
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2023to 30 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asa status 1-3
- surgical classification RENAL or PADUA score >9
Who cannot join
- BMI>30
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute
Roma, 00144
Ester Forastiere, MD, 0652662942 ext. + 39, forastiere@ifo.it
Maria Sofra, MD, 0652662942 ext. + 39, sofra@ifo.it
About this study
Official title: Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study
The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.
Read the detailed description
In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars
- Conditions
- Cancer of Kidney
- Being tested
- valveless trocar, standard trocar
- Keywords
- robotic nephrectomy, pneumoperitoneum, trocar valveless, general anesthesia, mechanical ventilation
- Medical subject headings
- Kidney Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valveless trocarDevice
Also called airseal
the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen
standard trocarDevice
standard trocar, usually camera port for robotic surgery
| Study group | Role | What they receive |
|---|---|---|
| trocar standard | Sham comparator | patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery Receives: Device: standard trocar |
| trocar valveless | Active comparator | patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery Receives: Device: valveless trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight
Measured: before extubation
Secondary outcomes (2)
postoperative acute pain: using the NRS scale
Measured: at 1 hour and at 4 hour after the end of surgery
subcutaneous emphysema: through clinical observation at the end of the intervention
Measured: at 30 minutes afetr the end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start8 Feb 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of KidneyStudies 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
- Model description
- control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, MD, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732857
- Sponsor's protocol ID
- 1795/22
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05732857
- Acronym / sponsor ID
- 1795/22
- Conditions
- Cancer of Kidney
- Keywords
- robotic nephrectomy, pneumoperitoneum, trocar valveless, general anesthesia, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 17 Feb 2023 (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.
The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.
Detailed description
In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used
| Arm | Type | Receives |
|---|---|---|
| trocar standard | Sham comparator | Device: standard trocarpatients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery |
| trocar valveless | Active comparator | Device: valveless trocarpatients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asa status 1-3
- surgical classification RENAL or PADUA score >9
Key exclusion criteria (1 listed)
- BMI>30
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 |
|---|---|---|
| valveless trocarAlso: airsealthe valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen | Device | trocar valveless |
| standard trocarstandard trocar, usually camera port for robotic surgery | Device | trocar standard |
Primary outcome
carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight
Time frame: before extubation
2 secondary outcomes
postoperative acute pain: using the NRS scale
Time frame: at 1 hour and at 4 hour after the end of surgery
subcutaneous emphysema: through clinical observation at the end of the intervention
Time frame: at 30 minutes afetr the end of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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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.
Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valveless trocar and standard trocar in people with Cancer of Kidney, run by Regina Elena Cancer Institute at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight (time frame: before extubation). 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 Feb 2023.