PRP injection
ProcedureInjection of PRP after fistulotomy in simple low anal fistula
NCT Number: NCT07248007
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).
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
Platelet-rich plasma(PRP) has been widely investigated and applied in several surgical fields because of its ability to promote tissue regeneration and accelerate healing. In orthopedic surgery, PRP has been used to enhance bone and tendon healing, particularly in the managementofchronictendinopathiesandfractures.Inplastic and reconstructive surgery,it has been applied to improve graft take, flap survival, and cosmetic outcomes in wound coverage.In maxillofacial and dental surgery, PRP has shown benefits in bone regeneration, implant integration, and periodontal healing. More recently, colorectal and general surgery have explored PRP for difficult-to-heal wounds, including anal fistula, where it has been demonstrated to shorten healing time and reduce recurrence rates
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
( multiple tracts, suprasphincteric, extrasphincteric, or high transsphincteric tracts.) -Underlying diseases that impair healing: (Crohn's disease, ulcerative colitis, tuberculosis, HIV infection, anorectal malignancy)
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).
Injection of PRP after fistulotomy in simple low anal fistula
Time frame: intra operative
messure the improvement of operative time between the PRP group and the non PRP group
Time frame: 12 months
messure the improvement of post operative pain between the 2 groups using the VIsual Analogue Scale (VAS) score
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Acronym: PRPIWHAFSAFRCT
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