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

Primary Purpose

Anal Fissure Chronic, PRP

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
prp injection
Anrecta
sitz bath
nutrition regulation
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fissure Chronic focused on measuring chronic anal fissure, medical treatment, platelet rich plasma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Karatay Medicana Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

PRP group

Arm Description

The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey)

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 12, 2020
Last Updated
March 29, 2022
Sponsor
KTO Karatay University
Collaborators
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04320498
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
January 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University
Collaborators
Istanbul Medipol University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure Chronic, PRP
Keywords
chronic anal fissure, medical treatment, platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey)
Arm Title
PRP group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
prp injection
Other Intervention Name(s)
Platelet rich plasma injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anrecta
Other Intervention Name(s)
rectoderm
Intervention Description
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
Intervention Type
Behavioral
Intervention Name(s)
sitz bath
Intervention Description
participants were told to take a hot water sitz bath once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
nutrition regulation
Intervention Description
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
Primary Outcome Measure Information:
Title
effects of PRP treatment on epithelization .
Description
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
Title
effect of PRP treatment on VAS scores
Description
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
Secondary Outcome Measure Information:
Title
effect of PRP treatment on symptoms
Description
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
Title
Comparison of the effect of treatments on pain according to the onset of symptoms of patients
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Between 18 and 65 years of age with chronic anal fissure were included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 .
Facility Information:
Facility Name
Karatay Medicana Üniversitesi
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

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