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Clinical Trials/NCT06092398
NCT06092398
Not yet recruiting
Not Applicable

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

Assiut University0 sites60 target enrollmentSeptember 2024
ConditionsAnal Fistula

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anal Fistula
Sponsor
Assiut University
Enrollment
60
Primary Endpoint
evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
April 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Hassan Thabet Ahmed

doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 60 patients with perianal fistula were in the age group between 20 to 60 years old

Exclusion Criteria

  • Thrombocytopenia
  • Patient with rectovaginal fistula
  • fistula with chronic cavities
  • Acute sepsis and patient were not willing undergo this type of treatment

Outcomes

Primary Outcomes

evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula

Time Frame: 3 year

evaluate effect of autologous platelet rich plasma and platelet rich fibrin glue in decreasing recurrence rate of anal fistula

Secondary Outcomes

  • to evaluate the role of platelet rich plasma and platelet rich fibrin glue in decreasing post operative complication of anal fistula(3 year)

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