Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

SB Istanbul Education and Research Hospital

Status: Unknown

Conditions: Anal Fissure; Perianal Fistula; Hemorrhoids

Treatments: Drug: Life7

Study type: Observational

Funder types: Other

Identifiers

NCT03780998

yeditepe university

Details and patient eligibility

About

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

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 5 patient groups

Group-1 (n: 50): Healthy cases

Description:

Control group

Treatment:

Drug: Life7

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

Description:

With perianal examination diagnosed of grade 1 hemorroidal disease

Treatment:

Drug: Life7

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

Description:

With perianal examination diagnosed of grade 2 hemorroidal disease

Treatment:

Drug: Life7

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

Description:

With perianal examination diagnosed of anal fissure cases

Treatment:

Drug: Life7

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

Description:

With perianal examination diagnosed of uncomplicated, simple perianal fistula cases

Treatment:

Drug: Life7