Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study).

Journal: Trials
PMID: 37596613

Abstract

Robot-assisted partial nephrectomy (RAPN) is the standard of care for small, localized kidney tumors. This surgery is conducted within a short hospital stay and can even be performed as outpatient surgery in selected patients. In order to allow early rehabilitation of patients, an optimal control of postoperative pain is necessary. High-pressure pneumoperitoneum during surgery seems to be the source of significant pain during the first hours postoperatively. Our study is a prospective, randomized, multicenter, controlled study which aims to compare post-operative pain at 24 h between patients undergoing RAPN at low insufflation pressure (7 mmHg) and those operated on at standard pressure (12 mmHg) using the AirSeal system.This trial is registered in the US National Library of Medicine Trial Registry (NCT number: NCT05404685).

Authors

  • Gaëlle Margue
    Department of Urology, Bordeaux University Hospital, Bordeaux, France - gaelle.margue@club.fr.
  • Pierre Bigot
    French Research Network on Kidney Cancer UroCCR, Bordeaux, France.
  • Alexandre Ingels
    Urology Department, Henri Mondor University Hospital, APHP, Paris, France.
  • Morgan Rouprêt
    Centre de Recherche sur les Pathologies Prostatiques, Paris, France; GRC No. 5 Predictive Onco-Urology, Hôpital Pitié-Salpêtrière, AP-HP, Sorbonne Université, Paris, France.
  • Thibaut Waeckel
    Department of Urology, Caen University Hospital, Caen, France.
  • Jean-Alexandre Long
    Urology Department, Grenoble University Hospital, Grenoble, France; TIMC-IMAG UMR CNRS 5525, Domaine de la Merci, La Tronche, France. Electronic address: JALong@chu-grenoble.fr.
  • Geraldine Pignot
    Department of Urology, Paoli-Calmettes Institute, Marseille, France.
  • Karim Bensalah
    Department of Urology, Rennes University Hospital, 2, rue Henri Le Guilloux, 35033, Rennes Cedex, France.
  • Hervé Lang
    Department of Urology, Strasbourg University and Regional Hospital, Strasbourg, France.
  • Jonathan Olivier
    Department of Urology, Lille University and Regional Hospital, Lille, France.
  • Franck Bruyere
    Department of Urology, University of Tours, Tours, France.
  • Matthieu Durand
    Urology, Andrology, Renal Transplant Unit, Hôpital Pasteur 2, Nice University Hospital, Nice, France.
  • Jean-Baptiste Beauval
    Department of Urology, University of Toulouse, Toulouse, France.
  • Richard Mallet
    Urology Department, Polyclinique Francheville, Perigueux, France.
  • Bastien Parier
    Department of Urology, Hôpital Bicêtre, Université Paris Saclay, APHP, Le Kremlin-Bicêtre, France.
  • Alexandre de la Taille
    Department of Urology, Hôpitaux Universitaires Henri Mondor, AP-HP, University of Creteil, Créteil, France.
  • Jean-Christophe Bernhard
    Department of Urology, University of Bordeaux, Bordeaux, France.

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