NCT05404685

Partial Nephrectomy in Low Pressure

Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Tumors Treated With Minimally Invasive Surgery

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-10-04
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2022-06-03
• Last updated: 2025-06-13

Locations

15 sites across 1 country: France