Dai Li, Jin Xiangren, Xie Haitao, He Tong, Cheng Honggang, Zhu Yinwu, Wang Liuxing, Huang Fu, Liang Baichuang, Gou Xin, Wang Qian, Wang Haibin
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550001, People's Republic of China.
The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.
Heliyon. 2023 Apr 24;9(5):e15578. doi: 10.1016/j.heliyon.2023.e15578. eCollection 2023 May.
The guidelinesthat specify whether antibiotic prophylaxis should be administered before laparoscopic clean-contaminated wound to prevent postoperative surgical site infection (SSI) need to be improved. Studies have shown that elective laparoscopic cholecystectomy with clean-contaminated wound does not require antibiotic prophylaxis. However, there are no studies on the effect of antibiotic prophylaxis on SSI after laparoscopic appendectomy for chronic appendicitis (LCA), which is a clean-contaminated wound.
We conducted a single-center, double-blind, randomized controlled clinical trial. A total of 106 effective patients were randomly divided into the antibiotic group and saline group. Cefuroxime or clindamycin was administered intravenously in the antibiotic group (n = 52). Saline (0.9%) was administered intravenously in the saline group (n = 54). Interventions were administered as a single dose 30 min before surgery.
Among the 106 effective patients (median age, 37 years old [IQR, 25-45]; females, 77 [72.6%]), there were 6 cases (5.70%) of SSI: 3 cases (5.56%) in the saline group and 3 cases (5.70%) in the antibiotic group (OR = 1.00, [95% CI (0.20-5.4)], P = 0.96). There were no significant differences in the clinical outcomes of anal exhaust time, postoperative complications, and the symptom of primary abdominal pain between the two groups.
For patients with chronic appendicitis undergoing laparoscopic appendectomy, preoperative intravenous antibiotic prophylaxis did not reduce the risk of SSI within 30 days of the surgery compared to the saline group.
Registration number of China Clinical Trials Registration Center: ChiCTR2100048336.
关于是否应在腹腔镜清洁-污染伤口手术前给予抗生素预防以防止术后手术部位感染（SSI）的指南需要改进。研究表明，择期腹腔镜胆囊切除术伴清洁-污染伤口无需抗生素预防。然而，对于慢性阑尾炎腹腔镜阑尾切除术（LCA）这一清洁-污染伤口手术，尚无关于抗生素预防对SSI影响的研究。
我们进行了一项单中心、双盲、随机对照临床试验。总共106例有效患者被随机分为抗生素组和生理盐水组。抗生素组（n = 52）静脉注射头孢呋辛或克林霉素。生理盐水组（n = 54）静脉注射生理盐水（0.9%）。干预措施在手术前30分钟单次给药。
在106例有效患者中（中位年龄37岁[四分位间距，25 - 45岁]；女性77例[72.6%]），有6例（5.70%）发生SSI：生理盐水组3例（5.56%），抗生素组3例（5.70%）（比值比 = 1.00，[95%置信区间（0.20 - 5.4）]，P = 0.96）。两组在肛门排气时间、术后并发症及原发性腹痛症状的临床结局方面无显著差异。
对于接受腹腔镜阑尾切除术的慢性阑尾炎患者，与生理盐水组相比，术前静脉给予抗生素预防并未降低术后30天内发生SSI的风险。
中国临床试验注册中心注册号：ChiCTR2100048336。
