Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06136325 |
| Other study ID # |
56 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 17, 2018 |
| Est. completion date |
October 27, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
