Lim Claire Yinn, Alonso Anaïs, Koh Yi Ying, Roydhouse Stephanie, McCormack Lalla, Deans Rebecca, Nesbitt-Hawes Erin, Rao Archana, Causer Louise, Abbott Jason A
School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, New South Wales, Australia (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh), New South Wales.
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia (Dr. Rao).
J Minim Invasive Gynecol. 2022 Aug;29(8):992-997. doi: 10.1016/j.jmig.2022.04.018. Epub 2022 May 2.
To determine the feasibility of a double-blinded randomized, placebo-controlled study in determining the efficacy of antibiotic prophylaxis in preventing postoperative infections (POIs) in elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions.
Double-blinded, randomized, placebo-controlled trial.
University-affiliated tertiary referral hospital in Sydney, Australia.
Women older than 18 years undergoing elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions were eligible for the study and approached.
Before surgery, participants were randomized to receive either 2-g cephazolin or placebo (10-mL normal saline) administered by the anesthetist. Participants and other research staff were blinded to group allocation.
The primary outcome was study feasibility measured by recruitment rates, compliance rates of drug administration, compliance rates of delivery, maintenance of double blinding, and follow-up rates. Secondary outcomes included rate of POIs, length of hospitalization, readmission to hospital, unscheduled presentations to healthcare facilities, and antibiotic-related reactions. Between February 2019 and March 2021, 170 patients were approached with 117 participants (68.8%) recruited and randomized. The study had a high compliance rate of trial drug delivery (95.7%) and a high follow-up rate (99.1%).
This pilot study has demonstrated feasibility of a large-scale study with a recruitment rate of 68% of patients approached and excellent trial drug delivery and follow-up rates. As anticipated, it is underpowered for identifying clinically significant findings for POI rates. A large-scale study is appropriate and essential to determine the health-related risks of antibiotic prophylaxis with an emphasis on antimicrobial stewardship. The sample size for a large-scale study is 1678 participants based on infection rates in this pilot study.
确定一项双盲随机、安慰剂对照研究在评估抗生素预防择期非子宫切除腹腔镜良性妇科手术术后感染（POIs）疗效方面的可行性。
双盲、随机、安慰剂对照试验。
澳大利亚悉尼的一所大学附属三级转诊医院。
年龄大于18岁、接受择期非子宫切除腹腔镜良性妇科手术的女性符合研究条件并被纳入研究。
手术前，参与者被随机分配接受由麻醉师给予的2克头孢唑林或安慰剂（10毫升生理盐水）。参与者和其他研究人员对分组情况不知情。
主要结局是通过招募率、药物给药依从率、分娩依从率、双盲维持情况和随访率来衡量的研究可行性。次要结局包括术后感染率、住院时间、再次入院率、非计划就诊率以及抗生素相关反应。在2019年2月至2021年3月期间，共接触了170名患者，其中117名参与者（68.8%）被招募并随机分组。该研究的试验药物给药依从率较高（95.7%），随访率也较高（99.1%）。
这项初步研究证明了大规模研究的可行性，招募率达到了接触患者的68%，试验药物给药和随访率均良好。正如预期的那样，该研究在确定术后感染率的临床显著结果方面的效力不足。进行一项大规模研究以确定抗生素预防的健康相关风险并强调抗菌药物管理是合适且必要的。根据这项初步研究中的感染率，大规模研究的样本量为1678名参与者。
