Department of Digestive Surgery, Xi Jing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Trials. 2022 May 23;23(1):436. doi: 10.1186/s13063-022-06235-7.
The optimal preoperative preparation for elective colorectal cancer surgery has been debated in academic circles for decades. Previously, several expert teams have conducted studies on whether preoperative mechanical bowel preparation and oral antibiotics can effectively reduce the incidence of postoperative complications, such as surgical site infections and anastomotic leakage. Most of the results of these studies have suggested that preoperative mechanical bowel preparation for elective colon surgery has no significant effect on the occurrence of surgical site infections and anastomotic leakage.
METHODS/DESIGN: This study will examine whether oral antibiotic bowel preparation (OABP) influences the incidence of anastomotic leakage after surgery in a prospective, multicentre, randomized controlled trial that will enrol 1500 patients who require colon surgery. The primary endpoint, incidence of anastomotic leakage, is based on 2.3% in the OABP ± mechanical bowel preparation (MBP) group in the study by Morris et al. Patients will be randomized (1:1) into two groups: the test group will be given antibiotics (both neomycin 1 g and metronidazole 0.9 g) the day before surgery, and the control group will not receive any special intestinal preparation before surgery, including oral antibiotics or mechanical intestinal preparation. All study-related clinical data, such as general patient information, past medical history, laboratory examination, imaging results, and surgery details, will be recorded before surgery and during the time of hospitalization. The occurrence of postoperative fistulas, including anastomotic leakage, will be recorded as the main severe postoperative adverse event and will represent the primary endpoint.
Ethics approval was obtained from the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20200173). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals. Protocol was revised on November 22, 2021, version 4.0.
ChiCTR2000035550 . Registered on 13 Aug 2020.
择期结直肠癌手术的最佳术前准备在学术界已争论了数十年。此前，多个专家团队研究了术前机械性肠道准备和口服抗生素是否能有效降低术后并发症（如手术部位感染和吻合口漏）的发生率。这些研究的大部分结果表明，择期结肠手术的术前机械性肠道准备对手术部位感染和吻合口漏的发生没有显著影响。
方法/设计：本研究将通过前瞻性、多中心、随机对照试验，观察口服抗生素肠道准备（OABP）是否会影响吻合口漏的发生率，该试验将纳入 1500 例需要结肠手术的患者。主要终点为吻合口漏的发生率，基于 Morris 等人研究中 OABP±机械性肠道准备（MBP）组的 2.3%。患者将按 1:1 随机分为两组：试验组于术前 1 天给予抗生素（新霉素 1g 和甲硝唑 0.9g），对照组术前不进行任何特殊肠道准备，包括口服抗生素或机械性肠道准备。所有与研究相关的临床数据，如一般患者信息、既往病史、实验室检查、影像学结果和手术细节，将在术前和住院期间记录。术后瘘管（包括吻合口漏）的发生将被记录为主要严重术后不良事件，作为主要终点。
本研究已获得中国临床试验注册中心伦理委员会的批准（ChiECRCT20200173）。该研究的结果将在多个研究会议上公布，并以同行评议期刊上的文章形式发表。方案于 2021 年 11 月 22 日修订，版本 4.0。
ChiCTR2000035550。于 2020 年 8 月 13 日注册。
