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直肠癌低位前切除术中电动吻合器与手动吻合器的随机对照试验比较研究

Randomized Controlled Trial Comparative Study in Powered and Manual Stapler in Low Anterior Resection of Rectal Cancer.

作者信息

Sirikurnpiboon Siripong

机构信息

Department of Surgery, College of Medicine, Rajavithi Hospital, Rangsit University, Bangkok, Thailand.

出版信息

Asian J Endosc Surg. 2025 Jan-Dec;18(1):e70132. doi: 10.1111/ases.70132.

DOI:10.1111/ases.70132
PMID:40798889
Abstract

BACKGROUND

Anastomotic leakage remains one of the most serious complications following low anterior resection (LAR) for rectal cancer. While powered circular staplers (PCS) have been introduced to improve surgical consistency and reduce technical errors, their clinical superiority over manual circular staplers (MCS) remains unclear.

METHODS

A randomized controlled trial was conducted from December 2022 to April 2025, enrolling 179 patients with mid-to-low rectal cancer scheduled for LAR. After applying exclusion criteria, 170 patients were included in the final analysis (79 in the MCS group and 91 in the PCS group). Baseline characteristics, intraoperative findings, and postoperative outcomes were compared. Multivariate logistic regression was used to identify risk factors for anastomotic leakage.

RESULTS

There were no statistically significant differences between groups in terms of overall complication rates or intraoperative outcomes, although the PCS group demonstrated higher estimated blood loss and longer operative time. The incidence of anastomotic leakage was higher in the PCS group (13.2%) compared to the MCS group (5.1%), though this difference did not reach statistical significance (p = 0.112). Notably, a longer interval between completion of neoadjuvant chemoradiotherapy (CRT) and surgery was significantly associated with increased leakage risk (mean: 16.90 vs. 10.97 weeks; p < 0.001). Multivariate analysis confirmed that extended time to surgery after CRT was an independent risk factor for anastomotic leakage.

CONCLUSION

Although the PCS group showed a trend toward higher anastomotic leakage rates, the difference was not statistically significant. The interval between CRT completion and surgery emerged as a significant predictor of leakage. Further research is needed to establish optimal timing for surgery post-CRT and to determine whether stapler type influences outcomes in high-risk patients.

摘要

背景

吻合口漏仍然是直肠癌低位前切除术(LAR)后最严重的并发症之一。虽然电动圆形吻合器(PCS)已被引入以提高手术的一致性并减少技术失误,但其相对于手动圆形吻合器(MCS)的临床优势仍不明确。

方法

于2022年12月至2025年4月进行了一项随机对照试验,纳入179例计划行LAR的中低位直肠癌患者。应用排除标准后,170例患者纳入最终分析(MCS组79例,PCS组91例)。比较了基线特征、术中发现和术后结果。采用多因素逻辑回归分析确定吻合口漏的危险因素。

结果

两组在总体并发症发生率或术中结果方面无统计学显著差异,尽管PCS组的估计失血量更高,手术时间更长。PCS组的吻合口漏发生率(13.2%)高于MCS组(5.1%),但这一差异未达到统计学显著性(p = 0.112)。值得注意的是,新辅助放化疗(CRT)结束至手术之间的间隔时间延长与漏出风险增加显著相关(平均:16.90 vs. 10.97周;p < 0.001)。多因素分析证实,CRT后手术时间延长是吻合口漏的独立危险因素。

结论

虽然PCS组的吻合口漏率有升高趋势,但差异无统计学显著性。CRT结束至手术之间的间隔时间是漏出的重要预测因素。需要进一步研究以确定CRT后手术的最佳时机,并确定吻合器类型是否影响高危患者的预后。

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