Long-term outcomes of a bioactive matrix enriched with an autologous platelet concentrate for the treatment of complex anal fistulae.

IF 2.9 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Techniques in Coloproctology Pub Date : 2025-03-05 DOI:10.1007/s10151-024-03102-2

I Maya, E Spada, M Martí-Gallostra, A Cirera de Tudela, G Pellino, E Espín-Basany

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Abstract

Background: Treating complex anal fistulae (CAF) remains a clinical challenge. Regenerative fistula treatment (RFT) with a bioactive matrix enriched with autologous platelet concentrate (Obsidian RFT®) has shown potential in healing CAF while preserving continence, but its long-term efficacy is still debated. This study aims to report the outcomes of RFT in patients with CAF.

Methods: A retrospective analysis of a prospective database of patients with CAF treated with RFT between February 2021 and November 2023 at a single center was conducted. Patients were included if they completed at least a 6-month follow-up. The primary outcome was fistula healing at last available follow-up. Secondary outcomes included unscheduled reoperation and anorectal function.

Results: A total of 31 patients were treated with Obsidian RFT, 17 of whom completed the 6-month follow-up. Nine of the patients were women. The median age was 47 (24-63) years, and eight had inflammatory bowel disease. High transsphincteric fistulae were observed in 52.9% of patients. At a median follow-up of 21.8 (8-36) months, a 53% success rate was achieved. Approximately half of patients required at least one additional procedure owing to CAF persistence or recurrence. There were no reports of morbidity or mortality, and no worsening of continence was observed.

Conclusions: This pilot study demonstrated that nearly half of the patients treated with RFT for CAF achieved long-term healing, with no adverse effects on continence and an excellent safety profile. Larger studies are needed to draw definitive conclusions.

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富含自体浓缩血小板的生物活性基质治疗复杂肛瘘的长期疗效。

背景：治疗复杂肛瘘（CAF）仍然是一个临床挑战。利用富含自体浓缩血小板的生物活性基质（Obsidian RFT®）进行再生瘘管治疗（RFT）已显示出在保留尿失禁的同时治疗CAF的潜力，但其长期疗效仍存在争议。本研究旨在报道CAF患者RFT的结果。方法：对2021年2月至2023年11月单中心接受RFT治疗的CAF患者前瞻性数据库进行回顾性分析。如果患者完成了至少6个月的随访，则纳入研究。最后随访的主要结果是瘘管愈合。次要结果包括未计划的再手术和肛门直肠功能。结果：共有31例患者接受了Obsidian RFT治疗，其中17例完成了6个月的随访。其中9名患者是女性。中位年龄为47岁（24-63岁），其中8例患有炎症性肠病。52.9%的患者出现高括约肌瘘。中位随访时间为21.8（8-36）个月，成功率为53%。由于CAF持续存在或复发，大约一半的患者需要至少一次额外的手术。没有发病率或死亡率的报告，也没有观察到尿失禁的恶化。结论：这项初步研究表明，近一半接受RFT治疗的CAF患者实现了长期愈合，对尿失禁没有不良影响，并且具有良好的安全性。需要更大规模的研究才能得出明确的结论。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Techniques in Coloproctology GASTROENTEROLOGY & HEPATOLOGY-SURGERY

CiteScore

5.30

自引率

9.10%

发文量

176

审稿时长

1 months

期刊介绍： Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.