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)

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...

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Published in:Current controlled trials in cardiovascular medicine 2023-08, Vol.24 (1), p.545-545, Article 545
Main 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
Format: Article
Language:English
Subjects:
Abdomen
Analgesics
Carbon dioxide
Care and treatment
Clinical trials
Consent
Evaluation
Hospitals
Insufflation pressure
Kidney cancer
Laparoscopy
Management
Methods
Nephrectomy
Pain
Pain, Postoperative
Patient outcomes
Patients
Performance evaluation
Post-operative pain
Prognosis
Recovery (Medical)
Robot-assisted partial nephrectomy
Robotic surgery
Robotics
Robots
Study Protocol
Surgeons
Surgery
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Summary: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).
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-023-07533-4