乙状结肠和直肠手术中的改良口服抗生素和机械肠道准备（OAMBP）与传统 OAMBP：多中心随机非劣效性试验。

IF 2.9 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Annals of Gastroenterological Surgery Pub Date : 2024-06-20 DOI:10.1002/ags3.12837

Sodai Arai, Marie Hanaoka, Shinichi Yamauchi, Hironobu Baba, Ryoichi Hanazawa, Hiroyuki Sato, Akihiro Hirakawa, Masanori Tokunaga, Yusuke Kinugasa

{"title":"乙状结肠和直肠手术中的改良口服抗生素和机械肠道准备（OAMBP）与传统 OAMBP：多中心随机非劣效性试验。","authors":"Sodai Arai, Marie Hanaoka, Shinichi Yamauchi, Hironobu Baba, Ryoichi Hanazawa, Hiroyuki Sato, Akihiro Hirakawa, Masanori Tokunaga, Yusuke Kinugasa","doi":"10.1002/ags3.12837","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aim</h3>\n \n <p>To evaluate whether the use of a laxative with reduced patient burden in oral antibiotics and mechanical bowel preparation (OAMBP) could prevent surgical site infection (SSI) in left-sided colon and rectal cancers.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This multicenter, non-blinded, randomized, non-inferiority trial included patients who underwent elective colorectal surgery for colorectal cancer in a university and community hospital in Japan from April 1, 2021 to March 31, 2023. We compared conventional OAMBP (polyethylene glycol, metronidazole, and kanamycin) (cOAMBP group) with modified OAMBP (sodium picosulfate hydrate, metronidazole, and kanamycin) (mOAMBP group). The primary outcome was overall incidence of SSI. Secondary outcomes were postoperative complications, degree of patient burden, and intraoperative bowel dilatation.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Among 119 patients, 112 were randomly assigned to the two groups, with 56 patients in each group. SSI occurred in three (5.4%) and five patients (8.3%) in the mOAMBP and cOAMBP groups, respectively (90% confidence interval [CI]: −12.8–5.3), with a 15% margin of non-inferiority. Anastomotic leakage occurred in no patient in the mOAMBP group and three patients (5.4%) in the cOAMBP group (<i>p</i> = 0.24). The cOAMBP group reported significantly more pain than the mOAMBP group (50 [90.9%] vs. 7 [12.5%] participants). The mOAMBP group showed significantly lesser bowel dilatation than the cOAMBP group (1 [1.8%] vs. 21 [37.5%] participants).</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>mOAMBP is safe and less burdensome, can reduce intraoperative bowel dilatation, and is non-inferior compared with cOAMBP in preventing SSI. Therefore, mOAMBP may be more suitable for sigmoid colon and rectal cancer.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>UMIN000043162 (http://www.umin.ac.jp/ctr/). Registered on January 28, 2021.</p>\n </section>\n </div>","PeriodicalId":8030,"journal":{"name":"Annals of Gastroenterological Surgery","volume":null,"pages":null},"PeriodicalIF":2.9000,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11533008/pdf/","citationCount":"0","resultStr":"{\"title\":\"Modified oral antibiotics and mechanical bowel preparation (OAMBP) versus conventional OAMBP for sigmoid colon and rectal surgery: A multicenter randomized non-inferiority trial\",\"authors\":\"Sodai Arai, Marie Hanaoka, Shinichi Yamauchi, Hironobu Baba, Ryoichi Hanazawa, Hiroyuki Sato, Akihiro Hirakawa, Masanori Tokunaga, Yusuke Kinugasa\",\"doi\":\"10.1002/ags3.12837\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>To evaluate whether the use of a laxative with reduced patient burden in oral antibiotics and mechanical bowel preparation (OAMBP) could prevent surgical site infection (SSI) in left-sided colon and rectal cancers.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This multicenter, non-blinded, randomized, non-inferiority trial included patients who underwent elective colorectal surgery for colorectal cancer in a university and community hospital in Japan from April 1, 2021 to March 31, 2023. We compared conventional OAMBP (polyethylene glycol, metronidazole, and kanamycin) (cOAMBP group) with modified OAMBP (sodium picosulfate hydrate, metronidazole, and kanamycin) (mOAMBP group). The primary outcome was overall incidence of SSI. Secondary outcomes were postoperative complications, degree of patient burden, and intraoperative bowel dilatation.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Among 119 patients, 112 were randomly assigned to the two groups, with 56 patients in each group. SSI occurred in three (5.4%) and five patients (8.3%) in the mOAMBP and cOAMBP groups, respectively (90% confidence interval [CI]: −12.8–5.3), with a 15% margin of non-inferiority. Anastomotic leakage occurred in no patient in the mOAMBP group and three patients (5.4%) in the cOAMBP group (<i>p</i> = 0.24). The cOAMBP group reported significantly more pain than the mOAMBP group (50 [90.9%] vs. 7 [12.5%] participants). The mOAMBP group showed significantly lesser bowel dilatation than the cOAMBP group (1 [1.8%] vs. 21 [37.5%] participants).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>mOAMBP is safe and less burdensome, can reduce intraoperative bowel dilatation, and is non-inferior compared with cOAMBP in preventing SSI. Therefore, mOAMBP may be more suitable for sigmoid colon and rectal cancer.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>UMIN000043162 (http://www.umin.ac.jp/ctr/). Registered on January 28, 2021.</p>\\n </section>\\n </div>\",\"PeriodicalId\":8030,\"journal\":{\"name\":\"Annals of Gastroenterological Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-06-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11533008/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Gastroenterological Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/ags3.12837\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Gastroenterological Surgery","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ags3.12837","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

目的：评估在口服抗生素和机械肠道准备（OAMBP）中使用可减轻患者负担的泻药能否预防左侧结肠癌和直肠癌手术部位感染（SSI）：这项多中心、非盲、随机、非劣效试验纳入了 2021 年 4 月 1 日至 2023 年 3 月 31 日期间在日本一所大学和社区医院接受结直肠癌择期手术的患者。我们比较了传统 OAMBP（聚乙二醇、甲硝唑和卡那霉素）（cOAMBP 组）和改良 OAMBP（皮磷酸钠水合物、甲硝唑和卡那霉素）（mOAMBP 组）。主要结果是 SSI 的总发生率。次要结果是术后并发症、患者负担程度和术中肠管扩张：在 119 名患者中，112 人被随机分配到两组，每组 56 人。mOAMBP组和cOAMBP组分别有3名（5.4%）和5名（8.3%）患者发生SSI（90%置信区间[CI]：-12.8-5.3），非劣效差为15%。mOAMBP 组无患者发生吻合口漏，cOAMBP 组有 3 名患者（5.4%）发生吻合口漏（p = 0.24）。cOAMBP 组报告的疼痛明显多于 mOAMBP 组（50 [90.9%] 对 7 [12.5%]）。结论：mOAMBP 安全且负担较轻，可减少术中肠管扩张，在预防 SSI 方面与 cOAMBP 相比并无劣势。因此，mOAMBP 可能更适合乙状结肠和直肠癌：umin000043162 (http://www.umin.ac.jp/ctr/)。注册日期：2021 年 1 月 28 日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

Modified oral antibiotics and mechanical bowel preparation (OAMBP) versus conventional OAMBP for sigmoid colon and rectal surgery: A multicenter randomized non-inferiority trial

Aim

To evaluate whether the use of a laxative with reduced patient burden in oral antibiotics and mechanical bowel preparation (OAMBP) could prevent surgical site infection (SSI) in left-sided colon and rectal cancers.

Methods

This multicenter, non-blinded, randomized, non-inferiority trial included patients who underwent elective colorectal surgery for colorectal cancer in a university and community hospital in Japan from April 1, 2021 to March 31, 2023. We compared conventional OAMBP (polyethylene glycol, metronidazole, and kanamycin) (cOAMBP group) with modified OAMBP (sodium picosulfate hydrate, metronidazole, and kanamycin) (mOAMBP group). The primary outcome was overall incidence of SSI. Secondary outcomes were postoperative complications, degree of patient burden, and intraoperative bowel dilatation.

Results

Among 119 patients, 112 were randomly assigned to the two groups, with 56 patients in each group. SSI occurred in three (5.4%) and five patients (8.3%) in the mOAMBP and cOAMBP groups, respectively (90% confidence interval [CI]: −12.8–5.3), with a 15% margin of non-inferiority. Anastomotic leakage occurred in no patient in the mOAMBP group and three patients (5.4%) in the cOAMBP group (p = 0.24). The cOAMBP group reported significantly more pain than the mOAMBP group (50 [90.9%] vs. 7 [12.5%] participants). The mOAMBP group showed significantly lesser bowel dilatation than the cOAMBP group (1 [1.8%] vs. 21 [37.5%] participants).

Conclusion

mOAMBP is safe and less burdensome, can reduce intraoperative bowel dilatation, and is non-inferior compared with cOAMBP in preventing SSI. Therefore, mOAMBP may be more suitable for sigmoid colon and rectal cancer.