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
Affiliations
Gaelle Margue
Urology Department, Bordeaux University Hospital
Pierre Bigot
Urology Department, Angers University Hospital
Alexandre Ingels
Urology Department, Henri Mondor University Hospital, APHP
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).
