Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320498
Recruitment Status : Active, not recruiting
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Istanbul Medipol University Hospital
Information provided by (Responsible Party):
Yusuf Tanrikulu, KTO Karatay University

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.

Condition or disease Intervention/treatment Phase
Anal Fissure Chronic PRP Biological: prp injection Drug: Anrecta Behavioral: sitz bath Dietary Supplement: nutrition regulation Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 15, 2020

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 Name: 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.
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 Name: Platelet rich plasma injection

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




Primary Outcome Measures :
  1. 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 increased 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 by 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.

  2. 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 decrease. 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 increased 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, in order to evaluate the middle period pain control and In the second month to evaluate the late period pain control.



Secondary Outcome Measures :
  1. 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 were recorded on enrolment. In connection with wound healing, we expect symptoms such as constipation, pruritus and bleeding to decrease. we assessed the decline in constipation, pruritus, and bleeding from the start of treatment. we record the symptoms of the patients on 10th Day , first month and second month. Thus, we compared the response to treatment in the early, middle and late periods.

  2. 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 decreases 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 in day 10 , months 1 and 2 in patients with fissures for less than 12 months than in those with fissures of longer duration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Between 18 and 65 years of age with chronic anal fissure were included
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320498


Locations
Layout table for location information
Turkey
Karatay Medicana Üniversitesi
Konya, Turkey
Sponsors and Collaborators
KTO Karatay University
Istanbul Medipol University Hospital
Publications:

Layout table for additonal information
Responsible Party: Yusuf Tanrikulu, Assoc Professor, KTO Karatay University
ClinicalTrials.gov Identifier: NCT04320498    
Other Study ID Numbers: 122
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Yusuf Tanrikulu, KTO Karatay University:
chronic anal fissure
medical treatment
platelet rich plasma
Additional relevant MeSH terms:
Layout table for MeSH terms
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases