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Completed

NCT Number: NCT06136325

Treatment of Anal Fistulas With Obsidian RFT®

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Minimal Invasive Surgery Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Platelet-rich Fibrin Foam Rectal Diseases Rectal Fistula

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obsidian RFP anal fistula surgery

Procedure

Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®

Primary outcomes

  1. Closure rate anal fistula

    Time frame: 24 months

    anal fistula closure rate according to documentation in the patient administration system

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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