Kidney Tumors Treated With Minimally Invasive SurgeryP-NeLoPNCT05404685
Partial Nephrectomy in Low Pressure
A study testing Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy and Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy in people with Kidney Tumors Treated With Minimally Invasive Surgery, run by University Hospital, Bordeaux at 15 sites in France.
Trial summary
The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumors Treated With Minimally Invasive Surgery
- What is being tested?
- Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy and Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 15 sitesFrance
- Study dates
- 4 Oct 2022to 29 Apr 2024
- 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
- Male or Female aged of 18 and over
- Planned transperitoneal RAPN for tumor with AirSeal system.
- Affiliation to or beneficiary of the French social security
- Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days.
- Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery
- Person deprived of liberty
- Person under trusteeship, curatorship or legal guardianship
- Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU d'Angers
Angers, 49933
Centre Hospitalier Universitaire de Bordeaux
Bordeaux
CHU de Caen
Caen, 14033
Hopital Henri-Mondor
Créteil, 94010
Hôpital Claude Huriez
Lille, 59037
Institut Paoli-Calmettes
Marseille, 13009
CHU de Nice
Nice, 06001
Hôpital Pitié-Salpétrière
Paris, 75011
Hôpital bicêtre
Paris, 94270
Polyclinique Francheville Périgueux
Périgueux, 24000
CHU de Poitiers
Poitiers, 86021
Clinique La Croix du Sud
Quint-Fonsegrives, 31130
CHU de Rennes
Rennes, 35033
CHRU de Strasbourg
Strasbourg, 67091
CHU de Tours
Tours, 37044
About this study
Official title: Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal
The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.
Read the detailed description
Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. For transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. It is universally recognized that the lower insufflation pressure, the better. However, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. The AirSeal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. The investigators then hypothesize that RAPN would be feasible and safe even in low pressure (7mm Hg) and may decrease post-operative patients' pain.
The investigators plan to describe the feasibility of Low Pressure RAPN at 7mm Hg (LP-RAPN) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. This will be achieved comparatively to RAPN performed at standard insufflation pressure of 12 mm Hg and through a single blinded randomized trial design.
The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.
- Being tested
- Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy, Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy
- Keywords
- kidney cancer, kidney tumor, robotic surgery, urology
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low insufflation pressure (7mm Hg) for Robotic Assisted Partial NephrectomyDevice
Use of insufflation pressure at 7 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system.
The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.
Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial NephrectomyDevice
Use of insufflation pressure at 12 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system.
The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.
| Study group | Role | What they receive |
|---|---|---|
| Transperitoneal RAPN with AirSeal system set to 7mmH. | Experimental | Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg Receives: Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy |
| transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg) | Active comparator | Control arm : Patient with standard insufflation pressure of 12 mm Hg Receives: Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of post-operative pain
intensity of pain measured by a numeric analogic scale (between 0 and 10)
Measured: 24 hours after surgery
Secondary outcomes (4)
Number of clamp procedures.
Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping)
Measured: at surgery
Main location and intensity of post-operative pain.
Determination of main location and intensity (visual analogic scale) of post operative pain (minimum=0 correspond to worse outcome; maximum =10 correspond to better outcome)
Measured: 6 hours and 48 hours after surgery
Length of surgery
determination of length of surgery in minutes
Measured: up to 30 Days
Estimated blood loss and intra-operative transfusion
Estimated blood loss (mL) and intra-operative transfusion
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start4 Oct 2022
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
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 Kidney Tumors Treated With Minimally Invasive SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404685
- Sponsor's protocol ID
- CHUBX 2020/62
- Acronym
- P-NeLoP
- Status last verified
- Jun 2025
- First submitted
- 27 Apr 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margue G, Bigot P, Ingels A, Roupret M, Waeckel T, Long JA, Pignot G, Bensalah K, Lang H, Olivier J, Bruyere F, Durand M, Beauval JB, Mallet R, Parier B, De La Taille A, Bernhard JC. Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study). Trials. 2023 Aug 19;24(1):545. doi: 10.1186/s13063-023-07533-4.
PubMed 37596613
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal
- ClinicalTrials.gov ID
- NCT05404685
- Acronym / sponsor ID
- P-NeLoP / CHUBX 2020/62
- Keywords
- kidney cancer, kidney tumor, robotic surgery, urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 3 Jun 2022 (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 main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.
Detailed description
Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. For transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. It is universally recognized that the lower insufflation pressure, the better. However, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. The AirSeal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. The investigators then hypothesize that RAPN would be feasible and safe even in low pressure (7mm Hg) and may decrease post-operative patients' pain.
The investigators plan to describe the feasibility of Low Pressure RAPN at 7mm Hg (LP-RAPN) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. This will be achieved comparatively to RAPN performed at standard insufflation pressure of 12 mm Hg and through a single blinded randomized trial design.
The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperitoneal RAPN with AirSeal system set to 7mmH. | Experimental | Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial NephrectomyPatient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg |
| transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg) | Active comparator | Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial NephrectomyControl arm : Patient with standard insufflation pressure of 12 mm Hg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female aged of 18 and over
- Planned transperitoneal RAPN for tumor with AirSeal system.
- Affiliation to or beneficiary of the French social security
- Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days.
- Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
Key exclusion criteria (5 listed)
- Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery
- Person deprived of liberty
- Person under trusteeship, curatorship or legal guardianship
- Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial
- -
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 |
|---|---|---|
| Low insufflation pressure (7mm Hg) for Robotic Assisted Partial NephrectomyUse of insufflation pressure at 7 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system. The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization. | Device | Transperitoneal RAPN with AirSeal system set to 7mmH. |
| Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial NephrectomyUse of insufflation pressure at 12 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system. The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization. | Device | transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg) |
Primary outcome
Intensity of post-operative pain
Time frame: 24 hours after surgery
intensity of pain measured by a numeric analogic scale (between 0 and 10)
4 secondary outcomes
Number of clamp procedures.
Time frame: at surgery
Main location and intensity of post-operative pain.
Time frame: 6 hours and 48 hours after surgery
Length of surgery
Time frame: up to 30 Days
Estimated blood loss and intra-operative transfusion
Time frame: at surgery
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 13 Jun 2025.
- Derived from this study: PubMed 37596613Margue G, Bigot P, Ingels A, Roupret M, Waeckel T, Long JA, Pignot G, Bensalah K, Lang H, Olivier J, Bruyere F, Durand M, Beauval JB, Mallet R, Parier B, De La Taille A, Bernhard JC. Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study). Trials. 2023 Aug 19;24(1):545. doi: 10.1186/s13063-023-07533-4.
- Individual participant dataSharing planned: No
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy and Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy in people with Kidney Tumors Treated With Minimally Invasive Surgery, run by University Hospital, Bordeaux at 15 sites in France.
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 5 inclusion and 5 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
Intensity of post-operative pain (time frame: 24 hours after surgery). 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 NCT05404685, 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 13 Jun 2025.