Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT)

NCT07248007 | Not Yet Recruiting Phase 1

• 1 other identifier: RPRFISULOTOMY
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anal fistula is a common benign anorectal condition characterized by an abnormal tract between the anal canal and perianal skin, often resulting from cryptoglandular infection. Surgical fistulotomy remains the standard treatment for simple low anal fistulas, with success rates exceeding 90% . However,wound healing following fistulotomy can be prolonged,ranging from 6-10 weeks,which affects patient comfort, quality of life, and return to normal activity (1,2). After a fistulotomy, the tract is laid open, leaving behind a raw wound extending from the anal canal to the perianal skin.Traditionally,this wound is left open to heal by secondary intention(granulation and epithelialization). In marsupialization, the cut wound edges (the mucosa and anoderm/skin) are sutured to the wound base.Thismakesthewoundshallowerandkeepsitopenfordrainage.Itpreventsadeepcavitythat would otherwise take longer to granulate and epithelialize. Marsupialization of the wound edges has been introduced as a modification of standard fistulotomy to improve healing outcomes. Several randomized trials have shown that marsupialization accelerates wound healing (by 1-4 weeks) and preserves sphincter function better compared to leaving the wound open, without increasing recurrence or complications (3,4,5).

Conditions

Simple Anal Fistula

Keywords

anal fistula

Outcome Measures

Primary Outcomes (1)

• Operative time

  messure the improvement of operative time between the PRP group and the non PRP group

  intra operative

Secondary Outcomes (1)

• Post operative pain

  12 months

Study Arms (2)

PRP injection

ACTIVE COMPARATOR

a group of patients with simple anal fistula that will be treated with PRP following fistulotomy

Procedure: PRP injection

Non PRP group

NO INTERVENTION

the other group that will be treated with fistulotomy only without PRP

Interventions

PRP injection PROCEDURE

Injection of PRP after fistulotomy in simple low anal fistula

PRP injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age18-65years. Both males and females. Clinical diagnosis of simple low anal fistula(confirmed by examination±imaging).
• Simple fistula is defined as:
• Fistula affecting less than one third of anal sphincter Fistula willnot affect sphincter function after surgery(no risk for fecal incontinence).
• All types of low fistula which will not affect anal continence after surgery.

You may not qualify if:

• Complex or high anal fistulas:
• ( multiple tracts, suprasphincteric, extrasphincteric, or high transsphincteric tracts.) -Underlying diseases that impair healing: (Crohn's disease, ulcerative colitis, tuberculosis, HIV infection, anorectal malignancy)
• Hematological disorders: coagulopathy, thrombocytopenia, or platelet dysfunction.
• Systemic factors:
• Uncontrolled diabetes mellitus. Immunosuppressive therapy (e.g., steroids, chemotherapy). Previous surgery for anal fistula (to avoid bias from scar tissue and recurrence)..
• Known allergy to any agents used in PRP preparation (rare, e.g., calcium chloride).

Sponsors & Collaborators

• Assiut University: lead

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

Central Study Contacts

Mohammed Osama, Resident

CONTACT

01110554779; zezoosama99@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Model Details: comparison between 2 groups of patients with simple anal fistula one group use PRP with fistulotomy in treatment and the other group only do fistulotomy

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-10