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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)

Authors :
Margue, Gaelle
Bigot, Pierre
Ingels, Alexandre
Roupret, Morgan
Waeckel, Thibaut
Long, Jean-Alexandre
Pignot, Géraldine
Bensalah, Karim
Lang, Hervé
Olivier, Jonathan
Bruyere, Franck
Durand, Matthieu
Beauval, Jean-Baptiste
Mallet, Richard
Parier, Bastien
De La Taille, Alexandre
Bernhard, Jean-Christophe
Source :
Trials. 8/18/2023, p1-8. 8p.
Publication Year :
2023

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). [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
17456215
Database :
Academic Search Index
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
170034958
Full Text :
https://doi.org/10.1186/s13063-023-07533-4