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)

Trials. 2023 Aug 19;24(1):545. doi: 10.1186/s13063-023-07533-4.

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: Insufflation pressure; Kidney cancer; Post-operative pain; Robot-assisted partial nephrectomy.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Feasibility Studies
  • Humans
  • Insufflation* / adverse effects
  • Multicenter Studies as Topic
  • Nephrectomy / adverse effects
  • Pain, Postoperative
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Robotics*

Associated data

  • ClinicalTrials.gov/NCT05404685