Briatico Daniel, Flageole Helene, Al-Shahwani Noora, Farrokhyar Forough, VanHouwelingen Lisa
McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, ON, Canada.
Division of Pediatric General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Pilot Feasibility Stud. 2024 May 25;10(1):85. doi: 10.1186/s40814-024-01476-6.
Infections after elective colorectal surgery remain a significant burden for patients and the healthcare system. Adult studies suggest that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after colorectal surgery. In children, there is limited evidence for either of these practices and the utility of combining oral antibiotics with mechanical bowel preparation remains uncertain.
This study aims to determine the feasibility of conducting a randomized controlled trial assessing the efficacy of oral antibiotics, with or without mechanical bowel preparation, in reducing the rates of post-operative infection in pediatric colorectal surgery. Participants aged 3 months to 18 years undergoing elective colorectal surgery will be randomized pre-operatively to one of three trial arms: (1) oral antibiotics; (2) oral antibiotics and mechanical bowel preparation; or (3) standard care. Twelve patients will be included in each trial arm. Feasibility outcomes of interest include the rate of participant recruitment, post-randomization exclusions, protocol deviations, adverse events, and missed follow-up appointments. Secondary outcomes include the rate of post-operative surgical site infections, length of hospital stay, time to full enteral feeds, reoperation, readmission, and complications.
If the results of this trial prove feasible, a multi-center trial will be completed with sufficient power to evaluate the optimal pre-operative bowel preperation for pediatric patients undergoing elective colorectal surgery.
ClinicalTrials.gov: NCT03593252.
择期结直肠手术后的感染对患者和医疗系统来说仍然是一个重大负担。成人研究表明，口服抗生素与机械肠道准备相结合在降低结直肠手术后感染方面是有效的。在儿童中，关于这些做法的证据有限，口服抗生素与机械肠道准备相结合的效用仍不确定。
本研究旨在确定进行一项随机对照试验的可行性，该试验评估口服抗生素（有无机械肠道准备）在降低小儿结直肠手术术后感染率方面的疗效。年龄在3个月至18岁之间接受择期结直肠手术的参与者将在术前随机分为三个试验组之一：（1）口服抗生素；（2）口服抗生素和机械肠道准备；或（3）标准护理。每个试验组将纳入12名患者。感兴趣的可行性结果包括参与者招募率、随机分组后的排除情况、方案偏差、不良事件和失访预约情况。次要结果包括术后手术部位感染率、住院时间、完全肠内喂养时间、再次手术、再次入院和并发症。
如果该试验结果证明可行，将完成一项多中心试验，并有足够的效力来评估接受择期结直肠手术的小儿患者的最佳术前肠道准备方法。
ClinicalTrials.gov：NCT03593252。
