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

NCT06092398 | Not Yet Recruiting

• 1 other identifier: PRP and PRFG in anal fistula
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

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

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

  3 year

Secondary Outcomes (1)

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

  3 year

Study Arms (1)

PRP and PRFG in anal fistula

EXPERIMENTAL

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

Other: PRP and PRFG in treatment of anal fistula

Interventions

PRP and PRFG in treatment of anal fistula OTHER

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

PRP and PRFG in anal fistula

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Abdollahi, Abbas, Elaheh Emadi, and Dariyoush Hamidi Alamdary.

  BACKGROUND

• Yeung JM, Simpson JA, Tang SW, Armitage NC, Maxwell-Armstrong C. Fibrin glue for the treatment of fistulae in ano--a method worth sticking to? Colorectal Dis. 2010 Apr;12(4):363-6. doi: 10.1111/j.1463-1318.2009.01801.x. Epub 2009 Feb 7.

  PMID: 19220380 BACKGROUND

• Ji, Lijiang, et al.

  RESULT

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• maha atwa, PHD

  Assiut University

  STUDY CHAIR

Central Study Contacts

marwa hassan thabet, master

CONTACT

01004748373; meromoro1010@gmail.com

mariam Ezzat, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-09