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Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

NCT ID: NCT03780998

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-01-01

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

Conditions

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Hemorrhoids Anal Fissure Perianal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group-1 (n: 50): Healthy cases

Control group

Life7

Intervention Type DRUG

Life7 will used on the perianal skin with finger tips

Group-2 (n:50): Grade 1 hemorroid

With perianal examination diagnosed of grade 1 hemorroidal disease

Life7

Intervention Type DRUG

Life7 will used on the perianal skin with finger tips

Group-3 (n:50): Grade 2 hemorroid

With perianal examination diagnosed of grade 2 hemorroidal disease

Life7

Intervention Type DRUG

Life7 will used on the perianal skin with finger tips

Group-4 (n:50): Anal fissure cases

With perianal examination diagnosed of anal fissure cases

Life7

Intervention Type DRUG

Life7 will used on the perianal skin with finger tips

Group-5 (n:50): Simple perianal fistula

With perianal examination diagnosed of uncomplicated, simple perianal fistula cases

Life7

Intervention Type DRUG

Life7 will used on the perianal skin with finger tips

Interventions

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Life7

Life7 will used on the perianal skin with finger tips

Intervention Type DRUG

Other Intervention Names

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Life 7

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University of Medical Sciences

OTHER

Sponsor Role collaborator

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erhan Aysan

MD Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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erhan aysan, MD Prof

Role: CONTACT

Phone: +905322034879

Email: [email protected]

Fikrettin Sahin, Prof

Role: CONTACT

Phone: +905338146547

Email: [email protected]

Other Identifiers

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yeditepe university

Identifier Type: -

Identifier Source: org_study_id