A Phase 4 interventional study of prp injection and Anrecta in Anal Fissure Chronic and PRP, sponsored by KTO Karatay University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by KTO Karatay University · Phase 4, Interventional, and Treatment
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.
. 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.
79 studies on the registry are indexed under Fissure in Ano; 14 are open to participants now.
This study's enrollment of 41 is below the median of 99 across 61 interventional studies indexed under Fissure in Ano.
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The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey)
Drug: Anrecta · Behavioral: sitz bath · Dietary Supplement: nutrition regulation
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
Biological: prp injection · Drug: Anrecta · Behavioral: sitz bath · Dietary Supplement: nutrition regulation
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
Also known as: Platelet rich plasma injection
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
Also known as: rectoderm
participants were told to take a hot water sitz bath once a day
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
effects of PRP treatment on epithelization .
In a clean surgical wound, the epithelial cells migrate downward to meet deep in the dermis. Migration ceases when the layer is rejuvenated. Following surgery, this process is normally complete within 48 hours. However, the process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. In chronic anal fissures, wound epithelization can be evaluated by inspection. Approximately 80 percent of the original strength of the tissue is obtained within six weeks. So we planned to make this assessment on the 10th Day, 1st Month, and 2nd Month for the reason I explained above. We considered the complete epithelization of the fissure as a complete healing. We evaluated patients with epithelialization in the midline but incomplete as partial epithelization.
Time frame: 10 days , 1 month and 2 months
effect of PRP treatment on VAS scores
Distribution of the effect of PRP treatment on VAS scores. The VAS is a simple scale with a length of 100 mm on which patients were asked to rate their pain from 0 (absence of pain) to 100 (worst pain imaginable). In connection with wound healing, we expect the pain to change. The process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. So we planned to make this assessment on the 10th Day to evaluate early pain control. we planned In the first month, to evaluate the middle period pain control and in the second month to evaluate the late period pain control.
Time frame: 10 days , 1 month and 2 months
effect of PRP treatment on symptoms
Distribution of the effect of PRP treatment on symptoms Presenting symptoms including constipation, pruritus, presence of skin tags, and bleeding was recorded on enrolment. In connection with wound healing, we expect symptoms such as constipation, pruritus, and bleeding to change. we assessed the decline in constipation, pruritus, and bleeding from the start of treatment. we record the symptoms of the patients on the 10th Day, the first month, and the second month. Thus, we compared the response to treatment in the early, middle, and late periods.
Time frame: 10 days , 1 month and 2 months
Comparison of the effect of treatments on pain according to the onset of symptoms of patients
The duration of the associated complaints and symptoms distinguishes acute from chronic anal fissures, which are evaluated and treated as conditions with different etiologies and physiology. Acute anal fissures have symptoms of \< 8 weeks duration. Chronic anal fissure symptoms have persisted for 8 weeks or longer. The effectiveness of medical treatment changes with time after the appearance of the first anal fissure symptoms and ultimately becomes less effective than surgery. we evaluated the effect of treatments on symptoms according to the onset of symptoms of patients. we evaluated VAS scores on day 10, months 1, and 2 in patients with fissures for less than 12 months than in those with fissures of longer duration.
Time frame: 10 days , 1 month and 2 months
Plan to share: No
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KTO Karatay University