Partial Nephrectomy in Low Pressure

University Hospital, Bordeaux280 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

280

Conditions

Kidney Tumors Treated With Minimally Invasive Surgery

Interventions

Low insufflation pressure (7mm Hg) for Robotic Assisted Partial NephrectomyDEVICE

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.

Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial NephrectomyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (15)

CHU d'Angers

Angers, France

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

CHU de Caen

Caen, France

Outcomes

Primary Outcomes

Intensity of post-operative pain

intensity of pain measured by a numeric analogic scale (between 0 and 10)

Time frame: 24 hours after surgery

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.