Partial Nephrectomy in Low Pressure (P-NeLoP)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Tumors Treated With Minimally Invasive Surgery
• Intervention / Treatment: Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy; Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy

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 Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
  • Bordeaux, France
    • Centre hospitalier Universitaire de Bordeaux
  • Caen, France, 14033
    • CHU de Caen
  • Créteil, France, 94010
    • Hopital Henri-Mondor
  • Lille, France, 59037
    • Hôpital Claude Huriez
  • Marseille, France, 13009
    • Institut Paoli-Calmettes
  • Nice, France, 06001
    • CHU de Nice
  • Paris, France, 75011
    • Hôpital Pitié-Salpêtrière
  • Paris, France, 94270
    • Hôpital Bicêtre
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Périgueux, France, 24000
    • Polyclinique Francheville Périgueux
  • Quint-Fonsegrives, France, 31130
    • Clinique La Croix du Sud
  • Rennes, France, 35033
    • CHU de Rennes
  • Strasbourg, France, 67091
    • CHRU de Strasbourg
  • Tours, France, 37044
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transperitoneal RAPN with AirSeal system set to 7mmH.; Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg	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.
Active Comparator: transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg); Control arm : Patient with standard insufflation pressure of 12 mm Hg	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clamp procedures.	Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping)	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)	6 hours and 48 hours after surgery
Length of surgery	determination of length of surgery in minutes	up to 30 Days
Estimated blood loss and intra-operative transfusion	Estimated blood loss (mL) and intra-operative transfusion	at surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plateau Pressure and PETCO2 60 minutes after incision		at surgery
Length of Hospital stay (days)	Determination of Length of Hospital stay (days)	up to 30 days after surgery
Number and Clavien-Dindo classification of intra and post-operative complications up to 30 days after surgery		up to 30 days after surgery
Pain-killer intake scoring during the first post-operative week (7days)		up to 7 days after surgery
Minutes between end of surgery and first time out of bed		up to Day 2
Minutes between end of surgery and resumption of feeding		up to Day 2 after surgery
Minutes between end of surgery and resumption of bowel function (stools)		up to day 7 after surgery
Cost difference between the two arms (€)		at surgery
Minutes between end of surgery and resumption of bowel function (gaz)		up to day 2 after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Estimated): April 4, 2024
• Study Completion (Estimated): May 4, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: kidney cancer; kidney tumor; robotic surgery; urology
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: CHUBX 2020/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No