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Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

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ClinicalTrials.gov Identifier: NCT03780998
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Tabriz University of Medical Sciences
Information provided by (Responsible Party):
Erhan Aysan, Yeditepe University

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

Condition or disease Intervention/treatment
Hemorrhoids Anal Fissure Perianal Fistula Drug: Life7

Detailed Description:

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


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
Group-1 (n: 50): Healthy cases
Control group
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Name: Life 7

Group-2 (n:50): Grade 1 hemorroid
With perianal examination diagnosed of grade 1 hemorroidal disease
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Name: Life 7

Group-3 (n:50): Grade 2 hemorroid
With perianal examination diagnosed of grade 2 hemorroidal disease
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Name: Life 7

Group-4 (n:50): Anal fissure cases
With perianal examination diagnosed of anal fissure cases
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Name: Life 7

Group-5 (n:50): Simple perianal fistula
With perianal examination diagnosed of uncomplicated, simple perianal fistula cases
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Name: Life 7




Primary Outcome Measures :
  1. Pain symtom differences [ Time Frame: six months ]
    Pain Scale from level 1 to level 10.

  2. Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4) [ Time Frame: six months ]
    Surgeon general physical examination

  3. Closing of anal fissur line [ Time Frame: six months ]
    Surgeon general physical examination. Fissur line is exist or not exist

  4. Lowering of leakage amount of perianal fistule [ Time Frame: six months ]
    Three grade: lower, same, more


Biospecimen Retention:   Samples Without DNA
histopathological evaluation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Older than 18 years old cases
Criteria

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

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): NCT03780998


Contacts
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Contact: erhan aysan, MD Prof +905322034879 ext 4130 erhanaysan@hotmail.com
Contact: Fikrettin Sahin, Prof +905338146547 ext 4130 fikrettinsahin@gmail.com

Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Tabriz University of Medical Sciences

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Responsible Party: Erhan Aysan, MD Prof, Yeditepe University
ClinicalTrials.gov Identifier: NCT03780998     History of Changes
Other Study ID Numbers: yeditepe university
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anus Diseases
Fistula
Hemorrhoids
Fissure in Ano
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases