Partial Nephrectomy in Low Pressure

Not Applicable

Completed

• Conditions: Kidney Tumors Treated With Minimally Invasive Surgery

• Registration Number: NCT05404685
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Study Start: 2022-10-04
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensity of post-operative pain	24 hours after surgery	intensity of pain measured by a numeric analogic scale (between 0 and 10)

Secondary Outcome Measures

Name	Time	Method
Number of clamp procedures.	at surgery	Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping)
Main location and intensity of post-operative pain.	6 hours and 48 hours after surgery	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)
Length of surgery	up to 30 Days	determination of length of surgery in minutes
Estimated blood loss and intra-operative transfusion	at surgery	Estimated blood loss (mL) and intra-operative transfusion

Trial Locations

Locations (15)

CHU d'Angers; 🇫🇷 Angers, France

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Caen; 🇫🇷 Caen, France

Hopital Henri-Mondor; 🇫🇷 Créteil, France

Hôpital Claude Huriez; 🇫🇷 Lille, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

CHU de Nice; 🇫🇷 Nice, France

Hôpital Pitié-Salpétrière; 🇫🇷 Paris, France

Hôpital bicêtre; 🇫🇷 Paris, France

CHU de Poitiers; 🇫🇷 Poitiers, France

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