NCT03780998

Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: SB Istanbul Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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)

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

Conditions

• Hemorrhoids
• Anal Fissure
• Perianal Fistula

Interventions

Type	Name	Description
DRUG	Life7	Life7 will used on the perianal skin with finger tips

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-01-01
• Completion: 2020-01-01
• First posted: 2018-12-19
• Last updated: 2018-12-21