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

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.