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单孔腹腔镜阑尾切除术的真实世界数据:一项针对276名个体的全德前瞻性队列研究。

Real-world data of single-incision laparoscopic appendectomy: a German-wide prospective cohort study among 276 individuals.

作者信息

Matzner Jula-Melina, Paasch Christoph, Stirn Victoria, Hunger Richard, Lünse Sebastian, Lippert Hans, Croner Roland, Mantke René

机构信息

Department of Urology, University Hospital Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg an der Havel, Germany.

Department of General Surgery, University Hospital Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg an der Havel, Germany.

出版信息

Ann Med Surg (Lond). 2025 Jul 10;87(8):4758-4764. doi: 10.1097/MS9.0000000000003478. eCollection 2025 Aug.

DOI:10.1097/MS9.0000000000003478
PMID:40787568
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12333717/
Abstract

BACKGROUND

Acute appendicitis is a common surgical emergency, with a lifetime risk of 8.6% in men and 6.7% in women. The standard of care is appendectomy, which can be performed using a single-incision laparoscopic approach. The evidence on single-incision laparoscopic appendectomy (SILA) is predominantly based on randomized controlled trials, often excluding patients with comorbidities or complex clinical profiles. This study aimed to generate real-world data (RWD) on adult patients undergoing SILA to assess its safety, feasibility, and clinical outcomes in routine practice. In addition, the study aimed to identify patient-specific risk factors for intraoperative and postoperative complications.

METHODS

Data were obtained from the prospective multicenter SILAP registry, which included adult patients (≥18 years) who underwent SILA between January 2012 and April 2016. Demographic and clinical data including perioperative outcomes, were collected. Inclusion criteria comprised the ability and willingness to provide informed consent, while exclusion criteria included participation in other interventional studies. A descriptive comparison with high-volume studies was performed, focusing on key perioperative outcomes, including complication rates, operative time, length of hospital stay, mortality, and conversion rate.

RESULTS

A total of 276 patients from 14 different hospitals in Germany who underwent SILA were included. The mean operative time was 50.9 minutes (standard deviation [SD] ± 27.6). The average postoperative length of stay was 3.6 days (SD ± 4.3), and the mortality rate was 0%. Intraoperative complications occurred in 1.8%, while 6.2% had postoperative complications. No significant associations were found between sex, age, body mass index, and American Society of Anesthesiologists classification and perioperative complications. In 96.4% of cases, the appendectomy was successfully completed using the single-incision technique.

CONCLUSION

SILA demonstrates safety and feasibility for managing acute appendicitis in routine clinical practice. The RWD supports outcomes of clinical trials. Further validation is required to confirm risk factors for complication of specific subgroups.

摘要

背景

急性阑尾炎是一种常见的外科急症,男性终生患病风险为8.6%,女性为6.7%。治疗的标准方法是阑尾切除术,可采用单切口腹腔镜手术方式进行。关于单切口腹腔镜阑尾切除术(SILA)的证据主要基于随机对照试验,这类试验通常会排除患有合并症或具有复杂临床特征的患者。本研究旨在收集接受SILA手术的成年患者的真实世界数据(RWD),以评估其在常规临床实践中的安全性、可行性和临床结局。此外,该研究旨在确定术中及术后并发症的患者特异性风险因素。

方法

数据来自前瞻性多中心SILAP注册库,其中包括2012年1月至2016年4月期间接受SILA手术的成年患者(≥18岁)。收集了包括围手术期结局在内的人口统计学和临床数据。纳入标准包括有能力且愿意提供知情同意书,而排除标准包括参与其他干预性研究。与大规模研究进行了描述性比较,重点关注关键围手术期结局,包括并发症发生率、手术时间、住院时间、死亡率和中转率。

结果

纳入了来自德国14家不同医院的276例接受SILA手术的患者。平均手术时间为50.9分钟(标准差[SD]±27.6)。术后平均住院时间为3.6天(SD±4.3),死亡率为0%。术中并发症发生率为1.8%,术后并发症发生率为6.2%。未发现性别、年龄、体重指数和美国麻醉医师协会分级与围手术期并发症之间存在显著关联。在96.4%的病例中,阑尾切除术通过单切口技术成功完成。

结论

SILA在常规临床实践中治疗急性阑尾炎显示出安全性和可行性。真实世界数据支持临床试验的结果。需要进一步验证以确认特定亚组并发症的风险因素。

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本文引用的文献

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Single-incision versus conventional multi-incision laparoscopic appendicectomy for suspected uncomplicated appendicitis.单切口与传统多孔腹腔镜阑尾切除术治疗疑似单纯性阑尾炎的比较。
Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD009022. doi: 10.1002/14651858.CD009022.pub3.
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The STROCSS 2024 guideline: strengthening the reporting of cohort, cross-sectional, and case-control studies in surgery.STROCSS 2024 指南:加强外科手术中队列研究、横断面研究和病例对照研究的报告。
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Single-incision compared with conventional laparoscopy for appendectomy in acute appendicitis: a systematic review and meta-analysis.经脐单孔腹腔镜与传统腹腔镜阑尾切除术治疗急性阑尾炎的系统评价和 Meta 分析。
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Surg Endosc. 2021 Jun;35(6):2997-3002. doi: 10.1007/s00464-020-07744-9. Epub 2020 Jun 16.
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