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Status: Bibliographieeintrag

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Verfasst von:Neuberger, Manuel [VerfasserIn]   i
 Kowalewski, Karl-Friedrich [VerfasserIn]   i
 Simon, Valentin [VerfasserIn]   i
 Hardenberg, Jost von [VerfasserIn]   i
 Siegel, Fabian [VerfasserIn]   i
 Wessels, Frederik [VerfasserIn]   i
 Worst, Thomas [VerfasserIn]   i
 Michel, Maurice Stephan [VerfasserIn]   i
 Westhoff, Niklas Christian [VerfasserIn]   i
 Kriegmair, Maximilian [VerfasserIn]   i
 Honeck, Patrick [VerfasserIn]   i
 Nuhn, Philipp [VerfasserIn]   i
Titel:Peritoneal flap for lymphocele prophylaxis following robotic-assisted radical prostatectomy with lymph node dissection
Titelzusatz:the randomised controlled phase 3 PELYCAN trial
Verf.angabe:Manuel Neuberger, Karl-Friedrich Kowalewski, Valentin Simon, Jost von Hardenberg, Fabian Siegel, Frederik Wessels, Thomas S. Worst, Maurice Stephan Michel, Niklas Westhoff, Maximilian C. Kriegmair, Patrick Honeck, Philipp Nuhn
E-Jahr:2024
Jahr:February 2024
Umfang:10 S.
Fussnoten:Online verfügbar: 4. August 2023, Artikelversion: 28. Januar 2024 ; Gesehen am 18.03.2025
Titel Quelle:Enthalten in: European urology oncology
Ort Quelle:Amsterdam : Elsevier, 2018
Jahr Quelle:2024
Band/Heft Quelle:7(2024), 1 vom: Feb., Seite 53-62
ISSN Quelle:2588-9311
Abstract:Background - Symptomatic lymphoceles (SLCs) after transperitoneal robotic-assisted radical prostatectomy with pelvic lymph node dissection (PLND) are common. Evidence from randomised controlled trials (RCTs) on the impact of peritoneal flaps (PFs) on lymphocele (LC) reduction is inconclusive. - Objective - To show that addition of PFs leads to a reduction of postoperative SLCs. - Design, setting, and participants - An investigator-initiated, prospective, parallel, double-blinded, adaptive, phase 3 RCT was conducted. Recruitment took place from September 2019 until December 2021; 6-month written survey-based follow-up was recorded. Stratification was carried out according to potential LC risk factors (extended PLND, diabetes mellitus, and anticoagulation) and surgeons; 1:1 block randomisation was used. Surgeons were informed about allocation after completion of the last surgical step. - Intervention - To create PFs, the ventral peritoneum was incised bilaterally and fixated to the pelvic floor. - Outcome measurements and statistical analysis - The primary endpoint was SLCs. Secondary endpoints included asymptomatic lymphoceles (ALCs), perioperative parameters, and postoperative complications. - Results and limitations - In total, 860 men were screened and 551 randomised. Significant reductions of SLCs (from 9.1% to 3.7%, p = 0.005) and ALCs (27.2% to 10.3%, p < 0.001) over the follow-up period of 6 mo were observed in the intention-to-treat analysis. Operating time was 11 min longer (p < 0.001) in the intervention group; no significant differences in amount (80 vs 103, p = 0.879) and severity (p = 0.182) of postoperative complications (excluding LCs) were observed. The survey-based follow-up might be a limitation. - Conclusions - This is the largest RCT evaluating PF creation for LC prevention and met its primary endpoint, the reduction of SLCs. The results were consistent among all subgroup analyses including ALCs. Owing to the subsequent reduction of burden for patients and the healthcare system, establishing PFs should become the new standard of care. - Patient summary - A new technique—creation of bilateral peritoneal flaps—was added to the standard procedure of robotic-assisted prostatectomy for lymph node removal. It was safe and decreased lymphocele development, a common postoperative complication and morbidity. Hence, it should become a standard procedure.
DOI:doi:10.1016/j.euo.2023.07.009
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1016/j.euo.2023.07.009
 Volltext: https://www.sciencedirect.com/science/article/pii/S2588931123001529
 DOI: https://doi.org/10.1016/j.euo.2023.07.009
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Evidence-based medicine
 Lymph node excision
 Lymphocele
 Pelvic lymphadenectomy
 Peritoneal flap
 Prostatectomy
 Prostatic neoplasms
 Randomised controlled trial
 Robotic surgery
 Urology
K10plus-PPN:1919955305
Verknüpfungen:→ Zeitschrift

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