Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of patietns with feasible PRS injection
研究概览
简要总结
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients presenting with significant symptoms of a rectovaginal fistula (RVF)
- •RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging [MRI] and/or endoanal ultrasound [EUS])
排除标准
- •Patients with active proctitis
- •Patients with the presence of associated (not properly drained)) pelvic abscess
- •Patients with immune suppressed status
- •Patients with hematological disorders
- •Patients with any oncological event in the five years prior to study
研究组 & 干预措施
Additional PRS-injection
Patients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS
干预措施: autologous platelet-rich stroma (Procedure)
结局指标
主要结局
Number of patietns with feasible PRS injection
时间窗: 1 day (day of surgery)
Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure.
次要结局
- Number of patients with safe PRS injection(30 days postoperatively)
- Number of patients with clinical closure(12 months)
- Number of re-interventions(12 months)
- Number of patients with radiological healing(12 months)
- Number of patients with recurrence(12 months)
研究者
Anne S. Nieuwstraten
BSc
Erasmus Medical Center