Treatment of Anal Fistulas With Obsidian RFT®

NCT ID: NCT06136325

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-17

Study Completion Date

2023-10-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anal Fistula Minimal Invasive Surgery Platelet-rich Fibrin Foam

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Obsidian RFP anal fistula surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christopher Dawoud

Principal Investigator; MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Dawoud, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Dawoud C, Girgis K, Stift A, Harpain F, Riss S. Treatment of anal fistulas with Obsidian RFT(R): just another autologous compound platelet-rich fibrin foam? Tech Coloproctol. 2024 Aug 2;28(1):93. doi: 10.1007/s10151-024-02968-6.

Reference Type DERIVED
PMID: 39095560 (View on PubMed)

Other Identifiers

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56

Identifier Type: -

Identifier Source: org_study_id

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