Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

Study Overview
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Brief Summary
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New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)

Detailed Description
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Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study. Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases

Official Title
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Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial

Conditions
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Hemorrhoids, Anal Fissure, Perianal Fistula

Intervention / Treatment
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* Drug: Life7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade 1 and 2 hemorroidal disease Cronic anal fissura Uncomplicated simple perianal fistula Exclusion Criteria: Any malign tumour Cronic colorectal disases Routine used of vasoactive medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group-1 (n: 50): Healthy cases<br>Control group | Drug: Life7<br>* Life7 will used on the perianal skin with finger tips<br>* Other names: Life 7;|
| Group-2 (n:50): Grade 1 hemorroid<br>With perianal examination diagnosed of grade 1 hemorroidal disease | Drug: Life7<br>* Life7 will used on the perianal skin with finger tips<br>* Other names: Life 7;|
| Group-3 (n:50): Grade 2 hemorroid<br>With perianal examination diagnosed of grade 2 hemorroidal disease | Drug: Life7<br>* Life7 will used on the perianal skin with finger tips<br>* Other names: Life 7;|
| Group-4 (n:50): Anal fissure cases<br>With perianal examination diagnosed of anal fissure cases | Drug: Life7<br>* Life7 will used on the perianal skin with finger tips<br>* Other names: Life 7;|
| Group-5 (n:50): Simple perianal fistula<br>With perianal examination diagnosed of uncomplicated, simple perianal fistula cases | Drug: Life7<br>* Life7 will used on the perianal skin with finger tips<br>* Other names: Life 7;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain symtom differences | Pain Scale from level 1 to level 10. | six months | 
| Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4) | Surgeon general physical examination | six months | 
| Closing of anal fissur line | Surgeon general physical examination. Fissur line is exist or not exist | six months | 
| Lowering of leakage amount of perianal fistule | Three grade: lower, same, more | six months |