None listed
Conditions
Brief summary
We are conducting a multi-centre placebo controlled randomised controlled trial to answer the question of whether antibiotic prophylaxis benefits patients in reducing the risk of surgical site infection. Despite our guidelines now largely stating antibiotics should not be used in non-hysterectomy benign gynaecological laparoscopies, antibiotic prophylaxis is still widely utilised in this setting, exposing patients to potential drug side effects for minimal benefit. This practice incurs additional costs to the healthcare system and may contribute to the rise in antimicrobial resistance. Our study aims to provide definitive evidence to guide clinicians and refine both local and international guidelines.
Interventions
Participants in this trial are those planning to undergo elective gynaecological laparoscopic surgery for benign conditions that are low risk of breach to bladder, bowel, uterine or vaginal cavities.
Participants will be randomised to receive surgical antibiotic prophylaxis or placebo in a 1:1 ratio. The trial drug will then be administered as follows. Participants assigned to antibiotic prophylaxis will receive:
• 2 grams intravenous Cefazolin reconstituted with water for injection to a total
Participants in this trial are those planning to undergo elective gynaecological laparoscopic surgery for benign conditions that are low risk of breach to bladder, bowel, uterine or vaginal cavities. Participants will be randomised to receive surgical antibiotic prophylaxis or placebo in a 1:1 ratio. The trial drug will then be administered as follows. Participants assigned to antibiotic prophylaxis will receive: • 2 grams intravenous Cefazolin reconstituted with water for injection to a total volume of 10 mililiters within 60 minutes (ideally 15-30 minutes) before surgical incision. • If the participant weighs >120 kilograms, a dose of 3 grams intravenous Cefazolin will be administered Participants assigned to placebo will receive: • 10 mililiters intravenous Normal Saline within 60 minutes (ideally 15-30 minutes) before surgical incision with a repeated dose if procedure >3 hours If the procedure is prolonged, then a second dose of the trial drug (either Cefazolin or placebo) may be administered 4 hours from the previous dose. The study team will complete the study operation data sheet which will include time of study test drug treatment administration, time of skin incision, length of operation, operative findings and procedures and any complications. All patients will be followed up post operatively at two points in time: 1. The “one week” follow up: 5-8 days after surgery participants will be reviewed by a doctor in the outpatient’s clinic. The assessing doctor will be blinded to the allocation of antibiotics or placebo intraoperatively. The doctor will assess for evidence of surgical site infection and collect appropriate samples when indicated to help clarify the diagnosis of surgical site infection. 2. The “four week” follow up: 25-32 days after surgery participants will attend their routine post-operative review appointment with a doctor. The assessing doctor will be blinded to the allocation of antibiotics or placebo intraoperatively.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or above • Planned laparoscopy for investigation and treatment of benign gynaecological disorders • Patient consent • For Australian sites: English speakers • For Israeli sites: Hebrew or English speakers
Exclusion criteria
• High suspicion of malignancy • Planned or high risk of breach of bladder/bowel/uterine/vaginal cavity o Hysterectomy o Myomectomy where breach of the endometrial cavity is predicted o Planned rectal shave, disc or segmental resection o Planned bladder resection or ureteric anastomosis • Allergy or contraindication to receive cefazolin. Contraindication to cefazolin includes patients with immediate hypersensitivity reactions to penicillins (eg urticarial, angio-oedema, bronchospasm, anaphylaxis) and/or history of adverse reaction to cefazolin. • Indication for the use of surgical antibiotic prophylaxis (such as mechanical heart valve or other prosthesis requiring surgical antibiotic prophylaxis, immunocompromised patient) • Infection present at time of surgery (PATOS): Evidence of infection at or adjacent to operative site before surgery (including current skin infection on abdominal wall, urinary tract infection, pelvic inflammatory disease, endometritis) • Emergency laparoscopies • Pregnancy
Outcome results
None listed