Treatment of Perianal Fistulas Through Injection of Autologous and Micro-fragmented Adipose Tissue: a Prospective Multicentre Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Healing
研究概览
简要总结
The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.
详细描述
STUDY BACKGROUND
Perianal fistulas are diseases that, by their nature, do not tend to heal spontaneously and are very rarely cured with medical treatment. Their healing is usually pursued through surgery, which often needs to be repeated due to the natural tendency of the fistulas to recur. A surgical treatment that is currently able to provide a high chance of healing is fistulotomy which, however, can injure the anal sphincter and may result in degrading scars and possible fecal incontinence. One possible strategy could be the lipofilling, i.e., autologous adipose tissue transplant containing, among the many, pericytes and progenitor cells, including adult mesenchymal stem cells.
STUDY DESIGN
This is a no profit interventional prospective multicenter study without drugs where 100 patients (10 each participant centre) with a diagnosis of trans-sphincteric anal fistula that is not suitable to be laid open will be enrolled.
After the enrolment, medical history and clinical data will be collected and pre-operatory exams will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes, aged over 18 and under 80 years old.
- •Diagnosis, confirmed by standard methods (magnetic resonance and/or trans anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open) without any secondary tracts and no active septic processes, performed 2-4 weeks after the first perianal access drainage procedure and fistulectomy, with positioning of a drainage seton.
- •Seton placed at least 4-6 weeks previously
- •No previous sphincter saving procedures for the anal fistula
- •No limitations to a periodic follow-up lasting for a total of 12 months
- •Informed consent form signed
排除标准
- •Patients with multiple fistulas
- •Active septic process
- •Patients unable to follow the pathway required by the protocol
- •Patients with active Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infections
- •Patients with Irritable Bowel Syndrome
- •Patients with rectal-vaginal fistulas
- •Patients with a history of cancer lasting less than 5 years
- •Patients undergoing cortisone and/or immunosuppressive and/or anticoagulant therapy
- •Patients with a history rectal or pelvic radiotherapy
- •Pregnant women
- •Patients with connective tissue diseases and/or coagulation diseases and/or uncompensated diabetes mellitus
- •Failure to sign the informed consent form
结局指标
主要结局
Healing
时间窗: 12 months
Closing of the fistula tract (internal and external orifice)
次要结局
- Non inferiority compared with the Advancement flap technique(12 months)
- Safety collecting all types of adverse events(12 months)
- Continence(12 months)
- Patient's satisfaction(12 months)
- Pain assessed using the Visual Analogue Scale (VAS) for pain(12 months)
研究者
Gabriele Naldini
Principal Investigator
Azienda Ospedaliero, Universitaria Pisana