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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transperitoneal RAPN with AirSeal system set to 7mmH. | Experimental | Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg |
|
| transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg) | Active Comparator | Control arm : Patient with standard insufflation pressure of 12 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of post-operative pain | intensity of pain measured by a numeric analogic scale (between 0 and 10) | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clamp procedures. | Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping) | at surgery |
| Main location and intensity of post-operative pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Plateau Pressure and PETCO2 60 minutes after incision | at surgery | |
| Length of Hospital stay (days) | Determination of Length of Hospital stay (days) | up to 30 days after surgery |
Inclusion Criteria:
Exclusion criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| Centre Hospitalier Universitaire de Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37596613 | Derived | 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. |
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The randomization list is drawn up by the statistician of the Center for Methodology and Data Management (USMR of the Bordeaux University Hospital) before starting the research.
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.
|
| Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy | Device | 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. |
|
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)
| 6 hours and 48 hours after surgery |
| Length of surgery | determination of length of surgery in minutes | up to 30 Days |
| Estimated blood loss and intra-operative transfusion | Estimated blood loss (mL) and intra-operative transfusion | at surgery |
| Number and Clavien-Dindo classification of intra and post-operative complications up to 30 days after surgery | up to 30 days after surgery |
| Pain-killer intake scoring during the first post-operative week (7days) | up to 7 days after surgery |
| Minutes between end of surgery and first time out of bed | up to Day 2 |
| Minutes between end of surgery and resumption of feeding | up to Day 2 after surgery |
| Minutes between end of surgery and resumption of bowel function (stools) | up to day 7 after surgery |
| Cost difference between the two arms (€) | at surgery |
| Minutes between end of surgery and resumption of bowel function (gaz) | up to day 2 after surgery |
| Bordeaux |
| France |
| CHU de Caen | Caen | 14033 | France |
| Hopital Henri-Mondor | Créteil | 94010 | France |
| Hôpital Claude Huriez | Lille | 59037 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| CHU de Nice | Nice | 06001 | France |
| Hôpital Pitié-Salpétrière | Paris | 75011 | France |
| Hôpital bicêtre | Paris | 94270 | France |
| Polyclinique Francheville Périgueux | Périgueux | 24000 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Clinique La Croix du Sud | Quint-Fonsegrives | 31130 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| CHU de Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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