Arai Sodai, Hanaoka Marie, Yamauchi Shinichi, Baba Hironobu, Hanazawa Ryoichi, Sato Hiroyuki, Hirakawa Akihiro, Tokunaga Masanori, Kinugasa Yusuke
Department of Gastrointestinal Surgery Tokyo Medical and Dental University Tokyo Japan.
Department of Surgery Edogawa Hospital Tokyo Japan.
Ann Gastroenterol Surg. 2024 Jun 20;8(6):1036-1045. doi: 10.1002/ags3.12837. eCollection 2024 Nov.
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.
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.
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 ( = 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).
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.
UMIN000043162 (http://www.umin.ac.jp/ctr/). Registered on January 28, 2021.
评估在口服抗生素及机械性肠道准备（OAMBP）中使用一种减轻患者负担的泻药是否能预防左侧结肠癌和直肠癌的手术部位感染（SSI）。
这项多中心、非盲、随机、非劣效性试验纳入了2021年4月1日至2023年3月31日期间在日本一家大学医院和社区医院接受择期结直肠癌手术的患者。我们将传统OAMBP（聚乙二醇、甲硝唑和卡那霉素）（cOAMBP组）与改良OAMBP（水合匹可硫酸钠、甲硝唑和卡那霉素）（mOAMBP组）进行了比较。主要结局是SSI的总体发生率。次要结局包括术后并发症、患者负担程度和术中肠扩张情况。
119例患者中，112例被随机分配至两组，每组56例。mOAMBP组和cOAMBP组分别有3例（5.4%）和5例（8.3%）发生SSI（90%置信区间[CI]：-12.8-5.3），非劣效界值为15%。mOAMBP组无患者发生吻合口漏，cOAMBP组有3例（5.4%）发生（P = 0.24）。cOAMBP组报告的疼痛明显多于mOAMBP组（50例[90.9%]对7例[12.5%]参与者）。mOAMBP组的肠扩张明显小于cOAMBP组（1例[1.8%]对21例[37.5%]参与者）。
mOAMBP安全且负担较小，可减少术中肠扩张，在预防SSI方面与cOAMBP相比非劣效。因此，mOAMBP可能更适用于乙状结肠癌和直肠癌。
UMIN000043162（http://www.umin.ac.jp/ctr/）。于2021年1月28日注册。
