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临床试验/NCT06092398
NCT06092398尚未招募不适用

Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

Assiut University0 个研究点目标入组 60 人开始时间: 2024年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Hassan Thabet Ahmed

doctor

Assiut University

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