An interventional study of Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy and Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy in Kidney Tumors Treated With Minimally Invasive Surgery, sponsored by University Hospital, Bordeaux. Completed at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 280 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
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Inclusion Criteria:
Exclusion criteria:
Exclusion Criteria:
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Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg
Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy
Control arm : Patient with standard insufflation pressure of 12 mm Hg
Device: Standard insufflation pressure (12mm 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.
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.
Intensity of post-operative pain
intensity of pain measured by a numeric analogic scale (between 0 and 10)
Time frame: 24 hours after surgery
Number of clamp procedures.
Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping)
Time frame: 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)
Time frame: 6 hours and 48 hours after surgery
Length of surgery
determination of length of surgery in minutes
Time frame: up to 30 Days
Estimated blood loss and intra-operative transfusion
Estimated blood loss (mL) and intra-operative transfusion
Time frame: at surgery
Plateau Pressure and PETCO2 60 minutes after incision
Time frame: at surgery
Length of Hospital stay (days)
Determination of Length of Hospital stay (days)
Time frame: up to 30 days after surgery
Number and Clavien-Dindo classification of intra and post-operative complications up to 30 days after surgery
Time frame: up to 30 days after surgery
Pain-killer intake scoring during the first post-operative week (7days)
Time frame: up to 7 days after surgery
Minutes between end of surgery and first time out of bed
Time frame: up to Day 2
Minutes between end of surgery and resumption of feeding
Time frame: up to Day 2 after surgery
Minutes between end of surgery and resumption of bowel function (stools)
Time frame: up to day 7 after surgery
Cost difference between the two arms (€)
Time frame: at surgery
Minutes between end of surgery and resumption of bowel function (gaz)
Time frame: up to day 2 after surgery
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux