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Observational Study
. 2024 Aug 2;28(1):93.
doi: 10.1007/s10151-024-02968-6.

Treatment of anal fistulas with Obsidian RFT®: just another autologous compound platelet-rich fibrin foam?

Affiliations
Observational Study

Treatment of anal fistulas with Obsidian RFT®: just another autologous compound platelet-rich fibrin foam?

C Dawoud et al. Tech Coloproctol. .

Abstract

Background: Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. The present study aimed to evaluate the efficacy and safety of Obsidian RFT®.

Methods: 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 and fistula characteristics and postoperative data were collected from electronic records following STROCSS criteria.

Results: Fifteen patients received Obsidian RFT® treatment for anal fistulas. We found no intra- and postoperative complications. The median hospital stay was 3 days. After a median follow-up of 32 months, a closure rate of 53.3% was detected. Non-significant differences were observed in various variables, yet trends emerged, indicating associations between abscess presence and non-healing fistulas. A distinct age threshold (≥ 42.7 years) served as an indicator for an inability to achieve anal fistula cure.

Conclusion: Obsidian RFT® represents a safe, minimally invasive operative procedure. Approximately half the patients experienced healing, with better outcome in a younger population.

Trial registration: Ethical Approval number Medical University of Vienna (#1258/2018). This study was registered retrospectively in ClinicalTrials.gov (NCT06136325).

Keywords: Anal fistula; Minimal invasive surgery; Obsidian; Platelet-rich fibrin foam.

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Conflict of interest statement

None of the authors has any conflict of interest to declare.

Figures

Fig. 1
Fig. 1
Two parts of the VIVOSTAD® System. A Applicator unit. The applicator unit is used for the controlled application of the Obsidian RFT® matrix to the area being treated. B Processing unit. The processing unit is used to prepare the patient's blood and to produce the bioactive Obsidian RFT® matrix
Fig. 2
Fig. 2
Distribution of surgery duration and length of hospital stay regarding healing (closure) of anal fistulas (n = 15)
Fig. 3
Fig. 3
A ROC function of age on the criterion of not curing AF (n = 15)

References

    1. Schwartz DA, Wiersema MJ, Dudiak KM, Fletcher JG, Clain JE, Tremaine WJ et al (2001) A comparison of endoscopic ultrasound, magnetic resonance imaging, and exam under anesthesia for evaluation of Crohn’s perianal fistulas. Gastroenterology 121(5):1064–1072 - PubMed
    1. Sonoda T, Hull T, Piedmonte MR, Fazio VW (2002) Outcomes of primary repair of anorectal and rectovaginal fistulas using the endorectal advancement flap. Dis Colon Rectum 45(12):1622–1628 - PubMed
    1. Sainio P (1984) Fistula-in-ano in a defined population: incidence and epidemiological aspects. Ann Chir Gynaecol 73(4):219–224 - PubMed
    1. Garg PK, Jain BK (2011) Seton drainage in high anal fistula. Int J Colorectal Dis 26(11):1495 - PubMed
    1. Lara FJ, Serrano AM, Moreno JU, Carmona JH, Marquez MF, Perez LR et al (2015) Platelet-rich fibrin sealant as a treatment for complex perianal fistulas: a multicentre study. J Gastrointest Surg 19(2):360–368 - PubMed

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