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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)
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...
| Autores principales: | , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2023
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10439590/ https://www.ncbi.nlm.nih.gov/pubmed/37596613 http://dx.doi.org/10.1186/s13063-023-07533-4 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Margue, Gaelle |
| collection | PubMed |
| description | 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). |
| format | Online Article Text |
| id | pubmed-10439590 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2023 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-104395902023-08-20 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 Trials Study Protocol 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). BioMed Central 2023-08-19 /pmc/articles/PMC10439590/ /pubmed/37596613 http://dx.doi.org/10.1186/s13063-023-07533-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Study Protocol 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 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) |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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) |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10439590/ https://www.ncbi.nlm.nih.gov/pubmed/37596613 http://dx.doi.org/10.1186/s13063-023-07533-4 |
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