Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Recurrence of fistulas
研究概览
简要总结
Rationale:
Closure of the internal opening is the most accepted standard procedure in the treatment of peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out of the three patients mucosal flap repair fails. Possible causal factors are incomplete clearance of pus and debris, incomplete closure of the internal opening, inappropriate host response in patients with risk factors like smoking or diabetes. Platelet derived growth factors may facilitate closure of the internal opening, especially in patients with impaired wound healing.
Objective:
The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of complex peri-anal fistula's.
Study design:
Randomized, multicenter trial.
Study population:
Patients with complex cryptoglandular peri-anal fistula's.
Intervention:
Injection of PRP in the curretted fistula track under the mucosal flap.
Main study parameters/endpoints:
- Recurrence rate
- Post-operative pain
- Continence
- Quality of life.
Nature and extent of the burden and risks associated with participation, group relatedness:
Because autologous blood is used, no extra risk are expected.
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
- None
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
- 否
入选标准
- •Complex peri-anal fistula.
- •Able to understand informed consent.
排除标准
- •Pregnancy
- •Local malignancy
- •Crohn's disease or Ulcerative colitis
- •Traumatic or iatrogenic lesion
- •Thrombocytopenia
- •Splenomegaly
- •Bleeding disorders
- •Hematologic malignancies
研究组 & 干预措施
Mucosa advancement flap
干预措施: Mucosa advancement flap (Procedure)
Mucosa advancement flap + PRP
Platelet rich plasma added to the mucosa advancement flap
干预措施: Mucosa advancement flap (Procedure)
Mucosa advancement flap + PRP
Platelet rich plasma added to the mucosa advancement flap
干预措施: Platelet rich plasma (PRP) (Other)
结局指标
主要结局
Recurrence of fistulas
时间窗: Assessed up to 104 weeks after operation
The surgeon or docter in the outpatient clinic will decide if there is a recurrent fistula or not. In case of doubt a MRI will be made.
次要结局
- Pain(Assessed at 104 weeks after operation)
- Quality of Life(Assessed at 16 weeks after operation)
- Incontinence(Assessed at 104 weeks after operation)
- Quality of life(Assessed at 104 weeks after operation)
- Pain(Assessed at 2 weeks after operation)
- Quality of Life(Assessed at 2 weeks after operation)
- Incontinence(Assessed at 2 weeks after operation)
- Pain(Assessed at 4 weeks after operation)
- Pain(Assessed at 16 weeks after operation)
- Pain(Assessed at 24 weeks after operation)
- Pain(Assessed at 52 weeks after operation)
- Quality of life(Assessed at 4 weeks after operation)
- Quality of life(Assessed at 24 weeks after operation)
- Quality of life(Assessed at 52 weeks after operation)
- Incontinence(Assesed at 4 weeks after operation)
- Incontinence(Assessed at 16 weeks after operation)
- Incontinence(Assessed at 52 weeks after operation)
- Incontinence(Assessed at 24 weeks after operation)