DOI: 10.26190/unsworks/1632
title: A Double-Blinded, Randomised, Placebo-Controlled Trial of Antibiotic Prophylaxis in Elective Non-Hysterectomy Laparoscopic Surgery for Benign Gynaecological Conditions

description: This dataset is for a study that aims to determine the feasibility of a double-blinded randomised, placebo-controlled study in determining the effectiveness of antibiotic prophylaxis in preventing postoperative infections in elective non-hysterectomy laparoscopic procedures for benign gynaecological conditions. Participants were randomly allocated into one of two groups - receiving 2g cephazolin and placebo (10mL normal saline) preoperatively. Data was collected pre-, intra- and post-operatively, including follow-up data collected at 2- and 6-weeks postoperatively. Primary outcomes analaysed include feasibility of a large-scales study and postoperative infection rates in both group. Secondary outcomes analysed include length of hospital stay, re-admission to hospital, unscheduled presentations to healthcare facilities and antibiotic-related reactions. It contains de-identified patient data including demographics, pre-, intra- and post-operative data, as well as follow-up data at 2-weeks and 6-weeks. Patients who have been withdrawn after randomisation are highlighted in yellow.
description: This double-blinded, randomised, placebo-controlled trial was conducted at a university-affiliated tertiary referral hospital in Sydney, Australia. Inclusion criteria were patients undergoing elective, non-hysterectomy laparoscopic surgery for benign gynaecological conditions; age over 18 years at the time of surgery; fluency in written and spoken English; and ability to understand the implications of their involvement in the study. Exclusion criteria were suspected or confirmed pregnancy; immunocompromise; documented history of allergy to cephalosporins and/or penicillin; and current involvement in another research project. Demographics, indication for surgery, previous infection history and current health status data were collected in an electronic case-report form. Randomisation was done in a 1:1 ratio in balanced blocks of 20 and followed a computer-generated randomisation. Allocation was conducted via a third-party telephone randomisation service after confirmation of eligibility. All trial packs were pre-made to contain either 2g cephazolin or placebo (10ml normal saline) in a tamper-proof identical container and stored in the hospital pharmacy. The trial pack matching the participant’s number was confirmed by research staff and a hospital pharmacist and delivered to the anaesthetist, who administered it to the patient prior to anaesthesia induction and ideally within 1 hour of the first surgical incision. Only the anaesthetist was aware of the study drug allocated to the participant. The patient, surgical team and study staff were blinded to the group allocation. Participants did not receive additional doses of antibiotics intraoperatively or postoperatively unless clinically indicated, in which case, all parties were unblinded and the participant was subsequently withdrawn from the trial. All surgeries were performed according to standard procedure by consultants and trainees in gynaecological surgery. Surgeon preference dictated the use of povidone-iodine or chlorhexidine solution for operative skin preparation. Details on time of anaesthesia induction, time of trial drug administration, time of first incision, time of final wound closure, primary procedure performed, method of entry into abdominal cavity, number, site and size of laparoscope ports, estimated blood loss, duration of catheterisation and length of stay (LOS) were collected. Data relating to hospital stay and follow-up were collected 2-weeks postoperatively via phone and at 6-weeks postoperatively via an in-person or phone consultation with the research team. Infections confirmed via microbiological testing were recorded as POIs, and included SSIs (wound infection and other sites, including endometritis and pelvic abscess), peritonitis, UTIs and febrile morbidity requiring therapeutic antibiotics. Primary outcomes measured were study feasibility and rate of POIs. Study feasibility was determined by recruitment rates, compliance rates of drug administration (allocated treatment is received), compliance rates of delivery (allocated treatment is given within an hour of surgical incision), maintenance of double blinding and follow-up rates. Secondary outcomes measured included the length of hospital stay, re-admission into hospital, unscheduled presentations to healthcare facilities and antibiotic-related reactions. All data collected were stored in an ethics-approved secure electronic database. Statistical analyses were undertaken using SPSS Statistics 26 (IBM, Armonk USA). Dichotomous data were compared using the Chi-square test, or Fisher’s exact test, as indicated. Continuous variables were assessed for normality using the Kolmogorov-Smirnov test with parametric data analysed by Student’s t test and non-parametric data analysed by Mann-Whitney U test. In this study p&lt;.05 is considered statistically significant. Given that this is a pilot study for feasibility, the sample size is derived based on funding received and is underpowered to determine a difference in the primary outcome of POI.