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临床试验/NCT03803917
NCT03803917已完成不适用

Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue

Lilli Lundby0 个研究点目标入组 21 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
主要终点
Clinical healing

研究概览

简要总结

Present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by liposuction was injected into the perianal fistulas. Primary objective was complete clinical healing six months after treatment. Secondary objectives were reduced or ceased fistula secretion and complications to the treatment.

详细描述

Investigators prospectively registered symptoms, complications and results of treatment in 21 patients with Crohn´s Disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria consisted of the following: the presence of complex CD fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and extent of the fistula. Clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. Primary endpoint was complete fistula healing at clinical examination six months after the last injection. A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination. Secondary endpoints included either reduced or ceased fistula secretion. If clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. A third injection was offered to patients who did not have complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Crohn´s Disease
  • presence of complex Crohn´s Disease fistulas
  • fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment.

排除标准

  • Fistulas developed following proctectomy were excluded.

研究组 & 干预措施

Treatment

Other

Injection with freshly collected autologous adipose tissue

干预措施: Injection with freshly collected autologous adipose tissue (Procedure)

结局指标

主要结局

Clinical healing

时间窗: 6 months after last injection

A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination

次要结局

  • Ceased or reduced fistula secretion(6 months after last injection)
  • Complications to the treatment(6 months after last injection)

研究者

发起方
Lilli Lundby
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lilli Lundby

Principal investigator

Aarhus University Hospital

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