Treatment of Anal Fistulas With Obsidian RFT®

Anal Fistula Clinical Trial

Official title:

Treatment of Anal Fistulas With Obsidian RFT® - a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06136325
• Other study ID #: 56
• Status: Completed
• Start date: January 17, 2018
• Est. completion date: October 27, 2023

Study information

• Verified date: November 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Description:

Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal passages between the anal canal and surrounding tissues. Traditional treatments, while effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence. Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. In this context, our retrospective study aims to evaluate the efficacy and safety of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its success in fistula closure and functional outcomes, thus contributing to the advancement of sphincter-preserving methods in anal fistula management.

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases.

Demographic, comorbidity, fistula characteristics, and postoperative data were collected from electronic records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 27, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna

Exclusion Criteria:

• unclear documentation

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Minimal Invasive Surgery
• Rectal Fistula

Intervention

Procedure:
• Obsidian RFP anal fistula surgery
Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure rate anal fistula	anal fistula closure rate according to documentation in the patient administration system	24 months