Kidney Tumors Treated With Minimally Invasive Surgery
Conditions
Keywords
kidney cancer, kidney tumor, robotic surgery, urology
Brief 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.
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.
Interventions
DEVICELow 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.
DEVICEStandard 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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of post-operative pain | 24 hours after surgery | intensity of pain measured by a numeric analogic scale (between 0 and 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of clamp procedures. | at surgery | Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping) |
| Main location and intensity of post-operative pain. | 6 hours and 48 hours after surgery | 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) |
| Length of surgery | up to 30 Days | determination of length of surgery in minutes |
| Estimated blood loss and intra-operative transfusion | at surgery | Estimated blood loss (mL) and intra-operative transfusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Plateau Pressure and PETCO2 60 minutes after incision | at surgery | — |
| Minutes between end of surgery and resumption of bowel function (gaz) | up to day 2 after surgery | — |
| Cost difference between the two arms (€) | at surgery | — |
| Length of Hospital stay (days) | up to 30 days after surgery | Determination of Length of Hospital stay (days) |
| 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 | — |
Countries
France
Outcome results
None listed