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临床试验/NCT03682627
NCT03682627Unknown不适用

PREventive Effect of FENestration With and Without Clipping on Post-Kidney Transplantation Lymphatic Complications: PREFEN Trial

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
Post kidney transplantation lymphocele

研究概览

简要总结

Post-Kidney Transplantation Lymphatic complications include lymphorrhea and lymphocele, and are some of the most challenging issues after kidney transplantation. The most frequent post-Kidney transplantation complication is accumulation of perirenal fluids, such as urinomas, hematomas, and lymphoceles. Lymphoceles are associated with morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Lymphoceles may also affect graft function by putting direct pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable. Peritoneal fenestration during kidney Transplantation is a simple method for preventing lymphocele formation. Recent studies have evaluated the effectiveness of clipping with metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. However, whether clipping prevents lymphocele formation after kidney transplantation has not been investigated. The aim of the proposed study is to compare the effect of fenestration with and without clipping on incidence of post-kidney transplantation lymphocele and lymphorrhea.

详细描述

Recent improvements in transplantation techniques, organ matching systems, and modern immunosuppressive regiments have made kidney transplantation a routine operation with acceptable mortality and morbidity rates. Post-kidney transplantation morbidities include vascular and urological complications, and postoperative fluid collections. Perirenal fluid collections, such as urinomas, hematomas, and lymphoceles, are some of most frequent complications following Kidney transplantation, among which post-Kidney transplantation lymphatic collections, are most challenging complications.

The incidence of post-kidney transplantation lymphatic complications is up to 50% and the peak incidence of lymphocele is during the 6th postoperative week (range: 2 weeks to 6 months).

Lymphoceles are usually asymptomatic and identified incidentally by routine ultrasound examination. However lymphoceles may result in morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Post-kidney transplantation lymphatic complications may also affect graft function by putting pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable.

Various preventive methods have been proposed in the literature. Lymphoceles usually originate from unligated lymphatic vessels, therefore precise ligation of donor and recipient lymphatic vessels can reduce lymphocele formation. Compression therapy of the lower limb after kidney transplantation and appropriate immunosuppressive therapy may also reduce lymphocele formation. Some authors have used polymeric sealants/hemostatic biomaterials or povidone-iodine to prevent lymphocele formation. However, the effectiveness and cost-efficiency of these methods has not been conclusively proven. Use of drains in lymphocele prevention has also been previously suggested, but this method remains controversial. Peritoneal fenestration at the time of kidney transplantation is a simple method to prevent lymphocele formation. This method has been widely studied in treatment and prevention of lymphoceles following kidney transplantation. However, to the best of our knowledge, only one randomized controlled trial has been performed to investigate the impact of preventive fenestration in prevention of post kidney transplantation lymphatic complications. This study showed that the prevalence of fluid collections in the fifth postoperative week was significantly higher in the standard group compared to fenestration group. Also, 15.5% of patients in the standard group developed symptomatic lymphoceles requiring treatment during the first postoperative year, versus 3.0% in the fenestration group.

Recent studies have evaluated the effectiveness of extensive clipping using metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. Some surgeons have declared concerns that larger fenestrations increase the risk of hernia. However, risk of closure of the peritoneal fenestration is higher for smaller Windows in the peritoneal cavity. Recently clipping of the edges of peritoneal fenestration was performed in the surgical clinic of the Heidelberg University Hospital to reduce risk of closure of the fenestration after kidney transplantation. However, whether fenestration and clipping prevents lymphocele formation after kidney transplantation has not been investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Provide written informed consent
  • Recipients of KTx from deceased donors

排除标准

  • Inability to comply with study and/or follow-up procedures
  • Recipients of KTx from living donors
  • Combined transplantation (e.g. pancreas-kidney transplantation)

研究组 & 干预措施

preventive fenestration

Active Comparator

Fenestration is performed at the time of kidney transplantation

干预措施: Fenestration (Procedure)

preventive fenestration and clipping

Experimental

Fenestration and clipping of the edges are performed at the time of kidney transplantation

干预措施: Fenestration and clipping (Procedure)

结局指标

主要结局

Post kidney transplantation lymphocele

时间窗: 6 months

Fluid collection of variable size located near to the transplanted kidney in a non-epithelialized cavity. The possibility that the accumulation of fluid is a hematoma, abscess, and urinoma will be ruled out after aspiration of the fluid.

次要结局

  • Post Kidney transplantation fluid collection(6 months)
  • Serum creatinine level(6 months)
  • Length of hospital stay(6 months)
  • Postoperative complications(6 months)
  • Lymphocele size(6 months)
  • Operation time(1 day)
  • Post Kidney transplantation lymphorrhea(6 months)
  • Blood Urea Nitrogen Level(6 months)
  • Plasma uric acid Level(6 months)
  • Glomerular filtration rate(6 months)
  • Estimated blood loss(1 day)
  • Mortality(90 days)
  • Lymphocele symptomes(6 months)
  • Lymphocele/lymphorrhea severity grade(6 months)
  • Retransplantion rate(6 months)
  • Rate of delayed graft function(30 days)
  • Rate of primary non-function grafts(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. A. Mehrabi

Professor Dr. med.

University Hospital Heidelberg

研究点 (2)

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