The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

Study Overview
=================
Brief Summary
-----------------
use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.

Detailed Description
-----------------
Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1. The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters). The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).

Official Title
-----------------
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

Conditions
-----------------
Fissure in Ano

Intervention / Treatment
-----------------
* Procedure: Platelet rich plasma injection
* Drug: Nitroglycerin ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • chronic anal fissure for more than three months Exclusion Criteria: medical comorbidity inflammatory bowel disease tuberculosis fissure HIV infected patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitroglycerin only<br>application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily. | Drug: Nitroglycerin ointment<br>* application of the ointment twice daily<br>* Other names: Rectocare - Ointment;|
| Experimental: platelet rich plasma injection<br>injection of platelet rich plasma under fissure base and edges | Procedure: Platelet rich plasma injection<br>* venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.<br>Drug: Nitroglycerin ointment<br>* application of the ointment twice daily<br>* Other names: Rectocare - Ointment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of fissure | Complete epithelization of fissure base | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of pain | Duration of pain after passing bowel motion measured in minutes | 3 months | 
| Pain change | Visual analog scale for measuring the intensity of pain (the higher score means the more severe the pain) explained as 0 represent no pain at all, and 10 represent the severest pain ever felt. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fissure in Ano, Platelet-Rich Plasma, Lateral Internal Sphincterotomy