Efficacy of injection of autologous adipose tissue in the treatment of patients with complex and recurrent fistula-in-ano of cryptoglandular origin.

IF 2.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Techniques in Coloproctology Pub Date : 2024-07-09 DOI:10.1007/s10151-024-02963-x

S Guillaumes, N J Hidalgo, I Bachero, R Pena, S T Nogueira, J Ardid, M Pera

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Abstract

Background: Adipose tissue injections, a rich source of mesenchymal stem cells, have been successfully used to promote anal fistula healing. This study aimed to investigate the efficacy of adipose tissue injection in treating patients with complex and recurrent fistulas of cryptoglandular origin.

Methods: We conducted a prospective, single-center, open-label, non-randomized, interventional clinical trial from January 2020 to December 2022. We enrolled nine patients, who were evaluated after at least 12 months of follow-up. All patients had seton removal, fistula tract excision or curettage, and a mucosal flap if possible or, alternatively, an internal opening suture. We used a commercially available system to collect and process adipose tissue prior to injection. This system allowed the collection, microfragmentation, and filtration of tissue.

Results: Selected cases included six men and three women with a median age of 42 (range 31-55) years. All patients had an extended disease course period, ranging from 3 to 13 (mean 6.6) years, and a history of multiple previous surgeries, including two to eight interventions (a mean of 4.4 per case). All fistulas were high transsphincteric, four cases horseshoe and two cases with secondary suprasphincteric or peri-elevator tract fistulas. Six cases (66%) achieved complete fistula healing at a mean follow-up of 18 (range 12-36) months. Three cases (33.3%) experienced reduced secretion and decreased anal discomfort.

Conclusions: In patients with complex and recurrent fistulas, such as the ones described, many from palliative treatments with setons, the adjuvant injection of adipose tissue might help achieve complete healing or improvement in a significant percentage of cases.

Clinicaltrials: The study protocol was prospectively registered on ClinicalTrials.gov (NCT04750499).

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注射自体脂肪组织治疗复杂和复发性隐窝瘘患者的疗效。

背景：脂肪组织注射是间充质干细胞的丰富来源，已成功用于促进肛瘘愈合。本研究旨在探讨脂肪组织注射治疗复杂和复发性隐窝源性肛瘘患者的疗效：2020年1月至2022年12月，我们开展了一项前瞻性、单中心、开放标签、非随机、介入性临床试验。我们招募了 9 名患者，对他们进行了至少 12 个月的随访评估。所有患者都进行了套管移除、瘘道切除或刮除术，如果可能，还进行了粘膜瓣手术，或者进行了内口缝合。在注射前，我们使用一种市售的系统来收集和处理脂肪组织。该系统可对组织进行收集、微碎和过滤：入选病例包括六名男性和三名女性，中位年龄为 42 岁（31-55 岁不等）。所有患者的病程都较长，从 3 年到 13 年（平均 6.6 年）不等，而且都曾接受过多次手术，包括 2 到 8 次介入治疗（平均每例 4.4 次）。所有瘘管均为高位经括约肌瘘，其中四例为马蹄形瘘，两例为继发性括约肌上瘘或电梯周围瘘。在平均 18 个月（12-36 个月）的随访中，有 6 例（66%）瘘管完全愈合。3例（33.3%）患者的分泌物减少，肛门不适感减轻：结论：对于复杂性和复发性肛瘘患者，如上述患者，很多都曾接受过肛门固定器的姑息治疗，注射脂肪组织辅助治疗可能有助于相当比例的病例实现完全愈合或改善：该研究方案已在ClinicalTrials.gov（NCT04750499）上进行了前瞻性注册。

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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.