Efficacy and safety of polyglycolic acid sheets for prevention of intra-abdominal infectious complications following minimally invasive surgery for gastric cancer: A prospective, multicenter, single-arm clinical trial

IF 2.3 4区医学 Q3 ONCOLOGY

Surgical Oncology-Oxford Pub Date : 2025-04-03 DOI:10.1016/j.suronc.2025.102224

Nobuaki Hoshino , Shigeo Hisamori , Seiichiro Kanaya , Hisahiro Hosogi , Dai Manaka , Yosuke Kinjo , Koichi Matsuo , Masazumi Sakaguchi , Masato Kondo , Yasutaka Nakanishi , Michihiro Yamamoto , Eiji Tanaka , Kosuke Toda , Hiroyasu Abe , Tatsuto Nishigori , Shigeru Tsunoda , Kazutaka Obama

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引用次数: 0

Abstract

Background

Serious intra-abdominal infectious complications are common after gastric cancer surgery, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess. Although polyglycolic acid sheets are often used to reinforce soft tissue and prevent postoperative complications in various types of surgery, including gastric cancer surgery, their effectiveness has not yet been fully demonstrated.

Methods

Patients with gastric cancer and no distant metastasis undergoing minimally invasive distal or total gastrectomy at Kyoto University Hospital or its 9 affiliated facilities between March 2022 and December 2023 were enrolled. The primary outcome was incidence of Clavien–Dindo (CD) grade ≥ III intra-abdominal infectious complications, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess. Secondary outcomes were incidence of overall complications (CD grade ≥ III), pancreatic fistula (CD grade ≥ III), or anastomotic leakage (CD grade ≥ III).

Results

In total, 210 patients were included. Distal gastrectomy was performed in 186 cases (88.6 %) and total gastrectomy in 24 (11.4 %). No cases required conversion to laparotomy. The incidence of CD grade III intra-abdominal infectious complications was 1.4 % (90 % confidence interval 0.6–3.5), below the pre-defined limit of 7.0 %. The rate of CD grade ≥ III overall complications was 4.3 %, that of CD grade ≥ III pancreatic fistula was 1.0 %, and that of CD grade ≥ III anastomotic leakage was 0.5 %. The polyglycolic acid sheet was not associated with any serious complications or abnormal laboratory values.

Conclusion

Polyglycolic acid sheets were safe and effective in preventing serious intra-abdominal infectious complications after minimally invasive surgery for gastric cancer.

Trial registry number

jRCTs052210188

查看原文本刊更多论文

聚乙醇酸片预防胃癌微创手术后腹腔感染并发症的有效性和安全性：一项前瞻性、多中心、单臂临床试验

背景：胃癌术后常见严重的腹腔内感染并发症，包括吻合口漏、胰瘘和腹腔内脓肿。尽管在各种类型的手术中，包括胃癌手术中，聚乙醇酸片常用于软组织加固和预防术后并发症，但其有效性尚未得到充分证明。方法纳入2022年3月至2023年12月在京都大学医院或其9个附属机构行微创胃远端或全胃切除术的无远处转移的胃癌患者。主要终点是Clavien-Dindo （CD）分级≥III级腹腔内感染并发症的发生率，包括吻合口漏、胰瘘和腹腔内脓肿。次要结局为总并发症（CD分级≥III）、胰瘘（CD分级≥III）或吻合口漏（CD分级≥III）发生率。结果共纳入210例患者。远端胃切除术186例（88.6%），全胃切除术24例（11.4%）。没有病例需要转为剖腹手术。CD III级腹腔内感染并发症的发生率为1.4%(90%可信区间0.6-3.5)，低于预先设定的7.0%。总并发症发生率为4.3%，胰瘘发生率为1.0%，吻合口瘘发生率为0.5%。聚乙醇酸片未与任何严重并发症或异常实验室值相关。结论聚乙醇酸片对预防胃癌微创术后严重腹腔感染并发症安全有效。试用注册号：jrcts052210188

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来源期刊

Surgical Oncology-Oxford 医学-外科

CiteScore

4.50

自引率

0.00%

发文量

169

审稿时长

38 days

期刊介绍： Surgical Oncology is a peer reviewed journal publishing review articles that contribute to the advancement of knowledge in surgical oncology and related fields of interest. Articles represent a spectrum of current technology in oncology research as well as those concerning clinical trials, surgical technique, methods of investigation and patient evaluation. Surgical Oncology publishes comprehensive Reviews that examine individual topics in considerable detail, in addition to editorials and commentaries which focus on selected papers. The journal also publishes special issues which explore topics of interest to surgical oncologists in great detail - outlining recent advancements and providing readers with the most up to date information.