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

NCT04320498 | Completed Phase 4

• 1 other identifier: 122
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fissure Chronic; PRP

Keywords

chronic anal fissure; medical treatment; platelet rich plasma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• effect of PRP treatment on symptoms

  10 days , 1 month and 2 months

• Comparison of the effect of treatments on pain according to the onset of symptoms of patients

  10 days , 1 month and 2 months

Study Arms (2)

control group

ACTIVE COMPARATOR

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 group

EXPERIMENTAL

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

Interventions

prp injection BIOLOGICAL

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

PRP group

Anrecta DRUG

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

Also known as: rectoderm

PRP group; control group

sitz bath BEHAVIORAL

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

PRP group; control group

nutrition regulation DIETARY_SUPPLEMENT

The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily

PRP group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Between 18 and 65 years of age with chronic anal fissure were included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• KTO Karatay University: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Karatay Medicana Üniversitesi

Konya, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 25, 2020
• Study Start: January 1, 2019
• Primary Completion: December 14, 2019
• Study Completion: January 2, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)