Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2022-10-04
2024-04-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
The numbers of the 2 strategy groups are balanced with a 1:1 ratio. The randomization will be stratified on the study centers and a detailed description of the analgesia practices of each center will be made at the beginning of the study.
The randomization will be done when the patient is under general anesthesia. Patients will not be told which group they have been randomized to.
Study Groups
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Transperitoneal RAPN with AirSeal system set to 7mmH.
Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg
Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy
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.
transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg)
Control arm : Patient with standard insufflation pressure of 12 mm Hg
Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy
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.
Interventions
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Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy
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 Nephrectomy
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
\-
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU d'Angers
Angers, , France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
CHU de Caen
Caen, , France
Hopital Henri-Mondor
Créteil, , France
Hôpital Claude Huriez
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
CHU de Nice
Nice, , France
Hôpital Pitié-Salpétrière
Paris, , France
Hôpital bicêtre
Paris, , France
Polyclinique Francheville Périgueux
Périgueux, , France
CHU de Poitiers
Poitiers, , France
Clinique La Croix du Sud
Quint-Fonsegrives, , France
CHU de Rennes
Rennes, , France
CHRU de Strasbourg
Strasbourg, , France
CHU de Tours
Tours, , France
Countries
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References
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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.
Other Identifiers
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CHUBX 2020/62
Identifier Type: -
Identifier Source: org_study_id
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