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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).
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.
Affiliation
  • Margue G; Urology Department, Bordeaux University Hospital, Bordeaux, France. gaelle.margue@chu-bordeaux.Fr.
  • Bigot P; Urology Department, Angers University Hospital, Angers, France.
  • Ingels A; Urology Department, Henri Mondor University Hospital, APHP, Paris, France.
  • Roupret M; Urology Department, Pitié-Saplétrière Hospital, APHP, Paris, France.
  • Waeckel T; Urology Department, Caen University Hospital, Caen, France.
  • Long JA; Urology Department, Grenoble Alpes University Hospital, Grenoble, France.
  • Pignot G; Urology Department, Paoli-Calmettes Institut, Marseille, France.
  • Bensalah K; Urology Department, Rennes University Hospital, Rennes, France.
  • Lang H; Urology Department, Strasbourg University Hospital, Strasbourg, France.
  • Olivier J; Urology Department, Lille University Hospital, Lille, France.
  • Bruyere F; Urology Department, Tours University Hospital, Tours, France.
  • Durand M; Urology Department, Nice University Hospital, Nice, France.
  • Beauval JB; Urology Department, La Croix du Sud Hospital, Quint-Fonsegrives, France.
  • Mallet R; Urology Department, Polyclinique Francheville, Perigueux, France.
  • Parier B; Urology Department, Kremlin Bicetre, APHP, Paris, France.
  • De La Taille A; Urology Department, Henri Mondor University Hospital, APHP, Paris, France.
  • Bernhard JC; Urology Department, Bordeaux University Hospital, Bordeaux, France.
Trials ; 24(1): 545, 2023 Aug 19.
Article in En | MEDLINE | ID: mdl-37596613
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).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Robotics / Insufflation Type of study: Clinical_trials / Guideline / Observational_studies Limits: Humans Language: En Journal: Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2023 Document type: Article Affiliation country: France
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Robotics / Insufflation Type of study: Clinical_trials / Guideline / Observational_studies Limits: Humans Language: En Journal: Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2023 Document type: Article Affiliation country: France