Anal FistulaNCT06136325
Treatment of Anal Fistulas With Obsidian RFT®
An observational study of Anal Fistula and Minimal Invasive Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anal Fistula, Minimal Invasive Surgery, Platelet-rich Fibrin Foam
- What is being tested?
- Obsidian RFP anal fistula surgery
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 17 Jan 2018to 27 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the final analysis.
Who may be able to join
- patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna
Who cannot join
- unclear documentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Obsidian RFP anal fistula surgery
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obsidian RFP anal fistula surgeryProcedure or surgery
Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure rate anal fistula
anal fistula closure rate according to documentation in the patient administration system
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start17 Jan 2018
- Primary completion31 Dec 2022
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Dawoud, Medical University of Vienna
- Investigators
- Christopher Dawoud, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136325
- Sponsor's protocol ID
- 56
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39095560
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anal Fistulas With Obsidian RFT® - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06136325
- Acronym / sponsor ID
- 56
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the final analysis.
Key inclusion criteria (1 listed)
- patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna
Key exclusion criteria (1 listed)
- unclear documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obsidian RFP anal fistula surgeryAnal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF® | Procedure or surgery | – |
Primary outcome
Closure rate anal fistula
Time frame: 24 months
anal fistula closure rate according to documentation in the patient administration system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39095560Dawoud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Dawoud, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula and Minimal Invasive Surgery, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure rate anal fistula (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.