Treatment of Anal Fistulas With Obsidian RFT®

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

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.

Study Overview

• Status: Completed
• Conditions: Anal Fistula; Minimal Invasive Surgery; Platelet-rich Fibrin Foam
• Intervention / Treatment: Procedure: Obsidian RFP anal fistula surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the final analysis.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure rate anal fistula	anal fistula closure rate according to documentation in the patient administration system	24 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Christopher Dawoud, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No