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真实世界中皮瓣手术的实践和结果:皮瓣窦治疗选择研究(PITSTOP)队列。

Real-world practice and outcomes in pilonidal surgery: Pilonidal Sinus Treatment Studying The Options (PITSTOP) cohort.

机构信息

Sheffield Clinical Trials Research Unit, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.

Academic Coloproctology, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK.

出版信息

Br J Surg. 2024 Mar 2;111(3). doi: 10.1093/bjs/znae009.

Abstract

BACKGROUND

Numerous surgical approaches exist for the treatment of pilonidal disease. Current literature on treatment is of poor quality, limiting the ability to define optimal intervention. The aim of this study was to provide real-world data on current surgical practice and report patient and risk-adjusted outcomes, informing future trial design.

METHODS

This UK-wide multicentre prospective cohort study, including patients (aged over 16 years) who had definitive treatment for symptomatic pilonidal disease, was conducted between May 2019 and March 2022. Patient and disease characteristics, and intervention details were analysed. Data on patient-reported outcomes, including pain, complications, treatment failure, wound issues, and quality of life, were gathered at various time points up to 6 months after surgery. Strategies were implemented to adjust for risk influencing different treatment choices and outcomes.

RESULTS

Of the 667 participants consenting, 574 (86.1%) were followed up to the study end. Twelve interventions were observed. Broadly, 59.5% underwent major excisional surgery and 40.5% minimally invasive surgery. Complications occurred in 45.1% of the cohort. Those who had minimally invasive procedures had better quality of life and, after risk adjustment, less pain (score on day 1: mean difference 1.58, 95% c.i. 1.14 to 2.01), fewer complications (difference 17.5 (95% c.i. 9.1 to 25.9)%), more rapid return to normal activities (mean difference 25.9 (18.4 to 33.4) days) but a rate of higher treatment failure (difference 9.6 (95% c.i. 17.3 to 1.9)%). At study end, 25% reported an unhealed wound and 10% had not returned to normal activities.

CONCLUSION

The burden after surgery for pilonidal disease is high and treatment failure is common. Minimally invasive techniques may improve outcomes at the expense of a 10% higher risk of treatment failure.

摘要

背景

目前有许多手术方法可用于治疗藏毛窦疾病。当前关于治疗的文献质量较差,限制了确定最佳干预措施的能力。本研究旨在提供当前手术实践的真实数据,并报告患者和风险调整后的结果,为未来的临床试验设计提供信息。

方法

这是一项在英国进行的多中心前瞻性队列研究,纳入了接受有症状藏毛窦疾病确定性治疗的患者(年龄超过 16 岁),研究时间为 2019 年 5 月至 2022 年 3 月。分析了患者和疾病特征以及干预措施的详细信息。在手术后的不同时间点收集了患者报告的结果数据,包括疼痛、并发症、治疗失败、伤口问题和生活质量。实施了策略来调整影响不同治疗选择和结果的风险。

结果

在同意参与的 667 名患者中,有 574 名(86.1%)随访至研究结束。观察到 12 种干预措施。总体而言,59.5%的患者接受了广泛的切除术,40.5%的患者接受了微创手术。该队列中有 45.1%的患者发生了并发症。接受微创手术的患者生活质量更好,且在风险调整后疼痛程度更低(第 1 天的评分:平均差异 1.58,95%置信区间 1.14 至 2.01)、并发症更少(差异 17.5(95%置信区间 9.1 至 25.9)%)、更快恢复正常活动(平均差异 25.9(18.4 至 33.4)天),但治疗失败率更高(差异 9.6(95%置信区间 17.3 至 1.9)%)。研究结束时,25%的患者报告伤口未愈合,10%的患者尚未恢复正常活动。

结论

藏毛窦疾病手术后的负担很高,且治疗失败很常见。微创手术可能会改善结果,但治疗失败的风险增加 10%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e8d/10941257/a065fb3e0481/znae009f1.jpg

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