Treatment of Anal Fistulas With Obsidian RFT®

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT06136325

Collaborator

(none)

Enrollment

Location

69.3

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anal Fistula Minimal Invasive Surgery Platelet-rich Fibrin Foam	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.

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 Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 17, 2018

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Oct 27, 2023

Outcome Measures

Primary Outcome Measures

Closure rate anal fistula [24 months]
anal fistula closure rate according to documentation in the patient administration system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Christopher Dawoud, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Christopher Dawoud, Principal Investigator; MD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT06136325

Other Study ID Numbers:

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Fistula

Fistula

Study Results

No Results Posted as of Nov 18, 2023