Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula
研究概览
简要总结
To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula
To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula
详细描述
An anal fistula (AF) is a tunnel connecting the anal canal or rectum (internal opening) with the skin (external opening) around the anus. Patients who have a perianal abscess have symptoms include discomfort, trouble sitting, and pus or blood discharge. Simple and complicated anal fistulas are the two types that exist. A complex fistula is difficult to manage, has a higher risk of recurrence rates, and poses a greater threat to continence after surgery. AF was associated with significant morbidity which is a devastating condition with profound effects on both the physical and psychological health of the patient.
Fibrin glue (also called fibrin sealant) is a surgical formulation used to create a fibrin clot for hemostasis, cartilage repair surgeries or wound healing. It contains separately packaged human fibrinogen and human thrombin. New procedures were published in the scientific literature, each with advantages and disadvantages. According to reports, an effective therapy option is the autologous fibrin glue that is rich in platelets.
PRP began to be used in surgery as a regenerative tissue factor
The tract fistula was cleaned with betadine 10% before PRP and PRFP were applied. Then, 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. The operation time was about 20-30 minutes, the clot formation usually takes about 8 minutes, but the anesthesia was extended to 20 minutes to make sure a complete clot in the place of fistula
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 patients with perianal fistula were in the age group between 20 to 60 years old
排除标准
- •Thrombocytopenia
- •Patient with rectovaginal fistula
- •fistula with chronic cavities
- •Acute sepsis and patient were not willing undergo this type of treatment
结局指标
主要结局
evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula
时间窗: 3 year
evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula
次要结局
- to evaluate the role of platelet rich plasma and platelet rich fibrin glue in decreasing post operative complication of anal fistula(3 year)
研究者
Marwa Hassan Thabet Ahmed
doctor
Assiut University
