NCT06136325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

October 29, 2023

Last Update Submit

November 14, 2023

Conditions

Anal FistulaMinimal Invasive SurgeryPlatelet-rich Fibrin Foam

Outcome Measures

Primary Outcomes (1)

  • Closure rate anal fistula

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

    24 months

Interventions

Obsidian RFP anal fistula surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • unclear documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 39095560DERIVED

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Dawoud, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; MD

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 18, 2023

Study Start

January 17, 2018

Primary Completion

December 31, 2022

Study Completion

October 27, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)