Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with Combined remission
研究概览
简要总结
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's age is over 18 at the time of surgery.
- •The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
- •The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
- •The patient received, understood and signed informed consent for active participation in the study.
- •The patient is able to understand the conditions of the study and to participate throughout the duration.
排除标准
- •Patients with more than 1 internal and 3 external openings.
- •Patients with ileus / colo ostomy.
- •Patients with anus / rectum-vaginal fistulas.
- •Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
- •Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
- •Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
- •Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Number of participants with Combined remission
时间窗: 24 weeks
The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses\> 3 mm in correspondence of the treated perianal fistulas
次要结局
- Number of participants with Clinical remission(2-4-8-12-24 weeks)