PDF(Pubmed)
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.
RESULTS: The study protocol was prospectively registered on ClinicalTrials.gov (NCT04750499).
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.
RESULTS: The study protocol was prospectively registered on ClinicalTrials.gov (NCT04750499).
摘要：
背景：脂肪组织注射，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腺源性瘘管的疗效。
方法：我们进行了前瞻性，单中心,开放标签，非随机化，2020年1月至2022年12月的介入临床试验。我们招募了9名患者,在至少12个月的随访后进行评估。所有的病人都有挂线手术,瘘管切除术或刮宫术，和粘膜瓣如果可能的话，或者，或者，内部开口缝线。我们使用市售系统在注射前收集和处理脂肪组织。这个系统允许收集，微破碎，和组织过滤。
结果：所选病例包括6名男性和3名女性，中位年龄为42岁（范围31-55岁）。所有患者的病程均延长，3至13年(平均6.6年)，和以前多次手术的历史，包括两到八个干预措施（平均每个病例4.4）。所有的瘘管都是高位经括约肌,马蹄形4例，继发性上括约肌或升降器周围瘘2例。6例（66％）在平均18个月（范围12-36个月）的随访中实现了完整的瘘管愈合。3例（33.3％）分泌减少，肛门不适减少。
结论：在复杂和复发性瘘管患者中，比如描述的，许多人来自与setons的姑息治疗，脂肪组织的辅助注射可能有助于在相当比例的病例中实现完全愈合或改善。
结果：研究方案在ClinicalTrials.gov（NCT04750499）上进行了前瞻性注册。
方法：我们进行了前瞻性，单中心,开放标签，非随机化，2020年1月至2022年12月的介入临床试验。我们招募了9名患者,在至少12个月的随访后进行评估。所有的病人都有挂线手术,瘘管切除术或刮宫术，和粘膜瓣如果可能的话，或者，或者，内部开口缝线。我们使用市售系统在注射前收集和处理脂肪组织。这个系统允许收集，微破碎，和组织过滤。
结果：所选病例包括6名男性和3名女性，中位年龄为42岁（范围31-55岁）。所有患者的病程均延长，3至13年(平均6.6年)，和以前多次手术的历史，包括两到八个干预措施（平均每个病例4.4）。所有的瘘管都是高位经括约肌,马蹄形4例，继发性上括约肌或升降器周围瘘2例。6例（66％）在平均18个月（范围12-36个月）的随访中实现了完整的瘘管愈合。3例（33.3％）分泌减少，肛门不适减少。
结论：在复杂和复发性瘘管患者中，比如描述的，许多人来自与setons的姑息治疗，脂肪组织的辅助注射可能有助于在相当比例的病例中实现完全愈合或改善。
结果：研究方案在ClinicalTrials.gov（NCT04750499）上进行了前瞻性注册。
