PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.

摘要: Introduction Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size plays important role its effectiveness. A large peritoneal window no longer indicated, due to herniation and difficulties performing biopsies. Small but will be closed too early. aim this study evaluate whether metal clips around edges a small result optimal effects with minimum size. Methods analysis This trial has been initiated July 2019 expected last 2 half years. All patients older than 18 years, who receive kidneys from deceased donors, included. recipients randomly allocated either control arm (small alone) or intervention clipping). fenestrations round, maximum cm, close hilum. Clipping performed eight (360°) every 45° oblique position. primary endpoint incidence symptomatic post-KTx complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative postoperative outcomes, including blood loss, operation time, severity grade lymphocele/lymphorrhea relative symptoms. Ethics dissemination protocol received approval Committee University Heidelberg (Registration Number S-318/2017). Standard Protocol Items: Recommendations Interventional Trials checklist available protocol. results disseminated through peer-reviewed journals conference presentations. Trial registration number ClinicalTrials.gov Registry (NCT03682627).