Transplant Evidence Alert

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

BMJ Open. 2020 Oct 13;10(10):e032286 doi: 10.1136/bmjopen-2019-032286.
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).

CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is the protocol for an interesting RCT in renal transplantation. Whilst there is prior existing evidence regarding prophylactic peritoneal fenestration, and even the size of fenestration, there is no evidence regarding clipping the edges of the window. The study protocol has good descriptions of the randomisation methods, blinding methods and statistical analysis. The power calculation has been done to detect a small difference in incidence (only 5%) at 6 months follow up, which may be too small to be clinically significant in the face of any potential complication, such as intestinal herniation.
Study Details
Aims: This protocol aims to examine the preventative effect of metal clips around the edges of a small fenestration on post-kidney transplantation lymphatic complications (PKTL).
Interventions: Participants will be randomised to one of two groups: with small fenestration only or with small fenestration and clipping around the edges.
Participants: Deceased donor kidney transplant reicipients.
Outcomes: The primary outcome is the incidence of post-transplant symptomatic lymphatic complications. The secondary outcomes include estimated blood loss, duration of operation, surgical complications, length of hospital stay, postoperative complications, all-cause mortality, total perirenal fluid accumulation, serum creatinine levels, blood urea nitrogen (BUN) level, glomerural filtration rate (GFR), delayed graft function and primary non-function.
Follow Up: 6 months
Metadata
Funding: No funding was received for this study
Publication type: Randomised Controlled Trial
Trial registration: ClinicalTrials.gov - NCT03682627
Organ: Kidney
Language: English
Author email: arianeb.mehrabi@med.uni-heidelberg.de
MeSH terms: Humans; Incidence; Kidney Transplantation; Lymphocele; Peritoneum; Randomized Controlled Trials as Topic