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).
Gaëlle MarguePierre BigotAlexandre IngelsMorgan RoupretThibaut WaeckelJean-Alexandre LongGéraldine PignotKarim BensalahHervé LangJonathan OlivierFranck BruyereMatthieu DurandJean-Baptiste BeauvalRichard MalletBastien ParierAlexandre De La TailleJean-Christophe BernhardPublished in: Trials (2023)
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).
Keyphrases
- robot assisted
- minimally invasive
- clinical trial
- end stage renal disease
- postoperative pain
- patients undergoing
- ejection fraction
- coronary artery bypass
- newly diagnosed
- healthcare
- chronic kidney disease
- study protocol
- randomized controlled trial
- prognostic factors
- pain management
- chronic pain
- phase ii
- phase iii
- emergency department
- coronary artery disease
- type diabetes
- open label
- acute coronary syndrome
- double blind
- surgical site infection
- patient reported outcomes
- cross sectional
- spinal cord
- atrial fibrillation