Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

PRP Clinical Trial

Official title:

Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320498
• Other study ID #: 122
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: January 2, 2021

Study information

• Verified date: March 2022
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2, 2021
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anal Fissure Chronic
• Fissure in Ano
• PRP

Intervention

Biological:
• prp injection
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.

Drug:
• Anrecta
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day

Behavioral:
• sitz bath
participants were told to take a hot water sitz bath once a day

Dietary Supplement:
• nutrition regulation
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily

Locations

Country	Name	City	State
Turkey	Karatay Medicana Üniversitesi	Konya

Sponsors (2)

Lead Sponsor	Collaborator
KTO Karatay University	Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 days , 1 month and 2 months
Primary	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.	10 days , 1 month and 2 months
Secondary	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.	10 days , 1 month and 2 months
Secondary	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.	10 days , 1 month and 2 months