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临床试验/NCT00367159
NCT00367159Unknown3 期

Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
14
试验地点
2
主要终点
Realization of an urethrocystography

研究概览

简要总结

Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively, medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive and not free of complication. Medical treatment is submissive to a good observance. The introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR elimination. Since the beginning of the endoscopic treatment, several bulking agents have been proposed. The ideal agent should be easy to inject, stable in time and should be safe. Of course it should be at least as efficient as actual bulking agent. The use of Teflon was the first wave of success of endoscopic treatment. But sudden passion of Teflon has been darkened by the notion of migration. Since, others substances have been proposed, autologous or exogenous, resorbable or not. But none was ideal and no solutions were found facing problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with Coleman who introduced a new technique called "lipostructure". This technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft. We propose to apply this technique to VRR management in children in order to combine innocuousness and efficiency.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • sexe : male and female
  • age : 3 to 15 years
  • written consent
  • Vesico-renal reflux staged I to III revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure.

排除标准

  • Before 3 years or older than 15 years
  • insulino-dépendant diabet
  • neurologic bladder
  • abnormalities of the urinary tract
  • kidney transplantation
  • past history of bladder surgery
  • anorexia (BMI <12)
  • Vesico-renal reflux staged IV or V
  • Active urinary tract infection

结局指标

主要结局

Realization of an urethrocystography

时间窗: at 3 months and 1 year

次要结局

  • Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years)(Day 1; Month 1; Month 3 ; Year 1; Year 5 and Year 10)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other

研究点 (2)

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