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

March 29, 2022 updated by: Yusuf Tanrikulu, KTO Karatay University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Karatay Medicana Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey)
Drug: Anrecta
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
Other Names:
  • rectoderm
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
Experimental: PRP group
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
Other Names:
  • rectoderm
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
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.
Other Names:
  • Platelet rich plasma injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of PRP treatment on epithelization .
Time Frame: 10 days , 1 month and 2 months
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
Time Frame: 10 days , 1 month and 2 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of PRP treatment on symptoms
Time Frame: 10 days , 1 month and 2 months
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
Comparison of the effect of treatments on pain according to the onset of symptoms of patients
Time Frame: 10 days , 1 month and 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KTO Karatay University

Collaborators

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 14, 2019

Study Completion (Actual)

January 2, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122 (Council for Stem Cell Sciences and Technologies)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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