Clinical trial NCT05404685: Partial Nephrectomy in Low Pressure
Official title: Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Tumors Treated With Minimally Invasive Surgery
Keywords: kidney cancer
kidney tumor
robotic surgery
urology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Intensity of post-operative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Number of clamp procedures.
timeFrame: at surgery
measure: Main location and intensity of post-operative pain.
timeFrame: 6 hours and 48 hours after surgery
measure: Length of surgery
timeFrame: up to 30 Days
measure: Estimated blood loss and intra-operative transfusion
timeFrame: at surgery
Other outcomes:
measure: Plateau Pressure and PETCO2 60 minutes after incision
timeFrame: at surgery
measure: Length of Hospital stay (days)
timeFrame: up to 30 days after surgery
measure: Number and Clavien-Dindo classification of intra and post-operative complications up to 30 days after surgery
timeFrame: up to 30 days after surgery
measure: Pain-killer intake scoring during the first post-operative week (7days)
timeFrame: up to 7 days after surgery
measure: Minutes between end of surgery and first time out of bed
timeFrame: up to Day 2
measure: Minutes between end of surgery and resumption of feeding
timeFrame: up to Day 2 after surgery
measure: Minutes between end of surgery and resumption of bowel function (stools)
timeFrame: up to day 7 after surgery
measure: Cost difference between the two arms (€)
timeFrame: at surgery
measure: Minutes between end of surgery and resumption of bowel function (gaz)
timeFrame: up to day 2 after surgery
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Créteil
country: France
facility: Hopital Henri-Mondor
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: Hôpital bicêtre
city: Poitiers
country: France
facility: CHU de Poitiers
city: Périgueux
country: France
facility: Polyclinique Francheville Périgueux
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Tours
country: France
facility: CHU de Tours
Study officials:
References: