La Raja Carlotta, Maroli Annalisa, Foppa Caterina, Gabbiadini Roberto, Dal Buono Arianna, Armuzzi Alessandro, Carvello Michele, Spinelli Antonino
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano - Milan, Italy.
J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024.
Crohn's perianal fistula represents a challenging condition to treat. Sphincters-preserving surgical techniques are increasingly being adopted as repeated surgical procedures may lead to various degrees of incontinence. This prospective study aims to assess the long-term efficacy of collagen paste application in patients with simple and complex Crohn's perianal fistulas.
Patients with Crohn's perianal fistula (simple or complex) and inactive luminal disease were enrolled. The fistula tract was treated by curettage and injection of acellular, porcine dermal collagen paste between 2019 and 2021. The primary endpoint was the clinical healing of the fistula at 12 and 24 months, defined as the absence of suppuration on clinical examination. The trial was preregistered on a public repository (ClinicalTrials.gov; NCT03776825).
Fourteen patients were included in the study, ten patients (71%) had complex perianal fistula. All patients underwent previous fistula operations. Nine patients (64%) reached complete clinical remission at 12 months, two patients (14%) had a clinical recurrence six months after surgery, and three patients (21%) at 12 months follow-up. Three relapsed patients presented postoperative abscesses. Twelve patients (86%) were followed up at 24 months, no further clinical recurrences or complications were observed and the complete healing rate was 58%. No continence disturbances were recorded after collagen paste injection.
The results suggest that collagen paste injection may represent a safe and effective option for Crohn's perianal fistulas, worth further investigation in larger trials.
克罗恩病肛周瘘是一种治疗颇具挑战性的疾病。由于反复手术可能导致不同程度的失禁，保留括约肌的手术技术越来越多地被采用。这项前瞻性研究旨在评估胶原蛋白糊剂应用于单纯性和复杂性克罗恩病肛周瘘患者的长期疗效。
纳入患有克罗恩病肛周瘘（单纯性或复杂性）且肠腔疾病处于静止期的患者。在2019年至2021年期间，通过刮除瘘管并注射无细胞猪真皮胶原蛋白糊剂来治疗瘘管。主要终点是在12个月和24个月时瘘管的临床愈合，定义为临床检查时无化脓。该试验已在公共数据库（ClinicalTrials.gov；NCT03776825）上预先注册。
14名患者纳入研究，10名患者（71%）患有复杂性肛周瘘。所有患者此前均接受过瘘管手术。9名患者（64%）在12个月时达到完全临床缓解，2名患者（14%）在术后6个月出现临床复发，3名患者（21%）在12个月随访时复发。3名复发患者出现术后脓肿。12名患者（86%）接受了24个月的随访，未观察到进一步的临床复发或并发症，完全愈合率为58%。注射胶原蛋白糊剂后未记录到控便障碍。
结果表明，注射胶原蛋白糊剂可能是克罗恩病肛周瘘安全有效的治疗选择，值得在更大规模试验中进一步研究。
