Trials (Aug 2023)

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)

  • Gaelle Margue,
  • Pierre Bigot,
  • Alexandre Ingels,
  • Morgan Roupret,
  • Thibaut Waeckel,
  • Jean-Alexandre Long,
  • Géraldine Pignot,
  • Karim Bensalah,
  • Hervé Lang,
  • Jonathan Olivier,
  • Franck Bruyere,
  • Matthieu Durand,
  • Jean-Baptiste Beauval,
  • Richard Mallet,
  • Bastien Parier,
  • Alexandre De La Taille,
  • Jean-Christophe Bernhard

DOI
https://doi.org/10.1186/s13063-023-07533-4
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 8

Abstract

Read online

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).

Keywords