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Status: Bibliographieeintrag

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Verfasst von:Golriz, Mohammad [VerfasserIn]   i
 Sabagh, Mohammad Sadegh [VerfasserIn]   i
 Mohammadi, Sara [VerfasserIn]   i
 Ghamarnejad, Omid [VerfasserIn]   i
 Khajeh, Elias [VerfasserIn]   i
 Mieth, Markus [VerfasserIn]   i
 Saeedi, Mohammed al [VerfasserIn]   i
 Diener, Markus K. [VerfasserIn]   i
 Mihaljevic, André Leopold [VerfasserIn]   i
 Morath, Christian [VerfasserIn]   i
 Zeier, Martin [VerfasserIn]   i
 Kulu, Yakup [VerfasserIn]   i
 Mehrabi, Arianeb [VerfasserIn]   i
Titel:PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN)
Titelzusatz:study protocol for a randomised controlled trial
Verf.angabe:Mohammad Golriz, Mohammadsadegh Sabagh, Sara Mohammadi, Omid Ghamarnejad, Elias Khajeh, Markus Mieth, Mohammed Al-Saeedi, Markus K. Diener, André L. Mihaljevic, Christian Morath, Martin Zeier, Yakup Kulu, Arianeb Mehrabi
E-Jahr:2020
Jahr:13 October 2020
Umfang:7 S.
Fussnoten:Gesehen am 19.11.2020
Titel Quelle:Enthalten in: BMJ open
Ort Quelle:London : BMJ Publishing Group, 2011
Jahr Quelle:2020
Band/Heft Quelle:10(2020,10) Artikel-Nummer e032286, 7 Seiten
ISSN Quelle:2044-6055
Abstract:Introduction Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size of the fenestration plays an important role in its effectiveness. A large peritoneal window is no longer indicated, due to herniation and difficulties in performing biopsies. Small preventive fenestration is effective but will be closed too early. The aim of this study is to evaluate whether metal clips around the edges of a small fenestration result in optimal effects with minimum fenestration size. - Methods and analysis This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms. - Ethics and dissemination This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations. - Trial registration number ClinicalTrials.gov Registry (NCT03682627).
DOI:doi:10.1136/bmjopen-2019-032286
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 ; Verlag: https://doi.org/10.1136/bmjopen-2019-032286
 Volltext: https://bmjopen.bmj.com/content/10/10/e032286
 DOI: https://doi.org/10.1136/bmjopen-2019-032286
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:clipping
 kidney transplantation
 lymphocele
 lymphorrhea
 preventive fenestration
K10plus-PPN:1739111435
Verknüpfungen:→ Zeitschrift

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