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Treatment of anal fistulas with Obsidian RFT®: just another autologous compound platelet-rich fibrin foam?
Techniques in Coloproctology ( IF 2.7 ) Pub Date : 2024-08-02 , DOI: 10.1007/s10151-024-02968-6
C Dawoud 1 , K Girgis 1 , A Stift 1 , F Harpain 1 , S Riss 1
Affiliation  

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).



中文翻译:


用黑曜石 RFT® 治疗肛瘘:只是另一种富含血小板的自体化合物纤维蛋白泡沫?


 背景


自体复合富含血小板的纤维蛋白泡沫等保留括约肌的技术越来越受欢迎,有可能在肛瘘治疗中获得更好的功能结果。本研究旨在评价 Obsidian RFT ® 的有效性和安全性。

 方法


该研究对 2018 年 1 月至 2022 年 12 月在维也纳医科大学普通外科接受黑曜石 RTF ® 封堵肛瘘的患者进行了回顾性分析。采用临床诊断辅以放射影像学检查,以确认不确定的病例。


按照 STROCSS 标准从电子记录中收集人口统计学和瘘管特征以及术后数据。

 结果


15 例患者接受了 Obsidian RFT® 治疗肛瘘。我们没有发现术中和术后并发症。中位住院时间为 3 天。中位随访 32 个月后,检测到 53.3% 的闭合率。


在各种变量中观察到不显著的差异,但出现了趋势,表明脓肿的存在与未愈合的瘘管之间存在关联。一个明确的年龄阈值 (≥ 42.7 岁) 是无法实现肛瘘治愈的指标。

 结论


Obsidian RFT ® 代表了一种安全、微创的手术程序。大约一半的患者经历了愈合,年轻人群的结果更好。

 试用注册


伦理批准号维也纳医科大学 (#1258/2018)。本研究于 ClinicalTrials.gov (NCT06136325) 进行回顾性注册。

更新日期:2024-08-03
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