Clinical trial NCT04320498: Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Official title: Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anal Fissure Chronic
PRP
Keywords: chronic anal fissure
medical treatment
platelet rich plasma
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2020-03-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autologous PRP currently has many uses in surgical and medical therapy. Compared with other regenerative therapies, PRP is easy-to-prepare, low-cost, and does not require complex equipment. The use of autologous PRP avoids immunological side effects. Data is lacking on the use of PRP in the treatment of anal fissure. This study evaluated PRP as an alternative medical treatment for chronic anal fissures.

Detailed description: . Chronic anal fissures are mucosal ulcers in the anal canal distal to the dentate line and most often present with severe pain and bleeding during defecation. The symptoms of chronic anal fissures persist for more than 8 weeks and do not respond well to medical treatment. This randomized controlled trial investigated the effects of PRP on the healing of chronic anal fissures, which can be considered as nonhealing ulcers. High anal sphincter pressure can cause chronic anal fissures by producing mucosal ischemia in the posterior anal canal that delays wound healing, ultimately resulting in a chronic nonhealing ulcer. Increased anal sphincter pressure induces constipation and spasms in the arterioles that form the mucosal blood supply.9 Botulinum toxin, calcium channel blockers, nitrates, or surgery promote healing by reducing anal sphincter pressure, and increasing blood flow.

Autologous PRP has been shown to speed recovery and improve pain and quality of life scores of patients treated for chronic wounds.PRP reduced complaints and accelerated epithelialization and healing in patients with chronic anal fissures. PRP, which can be obtained easily and did not have any harmful patient effects may be an alternative to surgery in patients with chronic anal fissures. The duration of symptoms should be considered during the evaluation of treatment options.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years of age with painful defecation of at least 2 months duration and diagnosed with anal fissure between January and October 2019 were included.
* The diagnosis of chronic anal fissure required :
* the presence of internal sphincter muscle fibers in the base of the fissure
* hypertrophic anal papillae on digital rectal examination

Exclusion Criteria:

* Patients with physical examination findings that did not meet the definition of chronic anal fissure
* with painful defecation for less than 2 months,
* atypical fissure location or multiple anal fissures away from the midline
* inflammatory bowel disease
* cancer
* history of trauma
* tuberculosis
* immune suppression
* sexually transmitted disease
* a disease possibly associated with a fissure
* a history of anal surgery
* previous treatment for anal fissure
* current pregnancy .

Primary outcomes:
measure: effects of PRP treatment on epithelization .
timeFrame: 10 days , 1 month and 2 months
measure: effect of PRP treatment on VAS scores
timeFrame: 10 days , 1 month and 2 months
Secondary outcomes:
measure: effect of PRP treatment on symptoms
timeFrame: 10 days , 1 month and 2 months
measure: Comparison of the effect of treatments on pain according to the onset of symptoms of patients
timeFrame: 10 days , 1 month and 2 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Karatay Medicana Üniversitesi
Study officials:
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