Partial Nephrectomy in Low Pressure (P-NeLoP)

University Hospital of Bordeaux

Status: Completed

Conditions: Kidney Tumors Treated With Minimally Invasive Surgery

Treatments: Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy; Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05404685

CHUBX 2020/62

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion Criteria:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Transperitoneal RAPN with AirSeal system set to 7mmH.

Experimental group

Description:

Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg

Treatment:

Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy

transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg)

Active Comparator group

Description:

Control arm : Patient with standard insufflation pressure of 12 mm Hg

Treatment:

Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy