None listed
Conditions
Brief summary
Surgical site infections are recognised as a common surgical complication, and the use of antibiotic prophylaxis has become an important method of reducing the risk of infection. However, given increasing concerns regarding antibiotic resistance, it is important that the use of antibiotic prophylaxis be evidence based. Local and international guidelines attempt to aid clinicians by outlining the evidence available for prophylaxis for various gynaecological procedures. The current Australian Therapeutic Guidelines recommend antibiotic prophylaxis for hysterectomy, termination of pregnancy and caesarean delivery, with no specific reference to non-hysterectomy complex laparoscopic procedures. Although anaphylactic reactions to cephalosporins are reported to be rare (0.001 to 0.1%), skin reactions such as urticaria, rash, exanthem and pruritis occur in 1-3% of patients. Other reported reactions include serum-sickness-like reaction, fever and immunohematologic reactions. Additionally, the potential costs of antibiotic resistance mean all clinicians have a heightened responsibility to ensure administration of antibiotics is for appropriate indications. Medicare data shows that at least 25000 non-hysterectomy, operative laparoscopic gynaecological procedures were performed in Australia last year. In view of the frequency with which such surgery is performed, there is a clear need for an appropriately powered study to examine whether there is a role for antibiotic prophylaxis for non-hysterectomy laparoscopic surgery in gynaecology. To ensure this a study of this magnitude can be carried out correctly, it is essential to perform this pilot study to assess the feasibility of future studies. Given the potential costs to both patients and the health-care system of post-operative infectious morbidity, as well as the costs of using antibiotics, including the actual cost of drug administration, adverse reactions in individual patients, and potential increases in antibiotic resistance, the results of this study have the potential to significantly impact both local and international policy in this area.
Interventions
2g intravenous Cephazolin made into a 10ml solution, given within 30min prior to the beginning of Laparoscopic Surgery
Sponsors
Royal Hospital for Women
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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
1. Patients requiring an elective laparoscopic procedure (that does not include hysterectomy) for a benign gynaecological condition as determined jointly by the surgeon and the patient. 2. English speaking. 3. Over 18 years of age at time of surgery. 4. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up. 5. Patients who are capable of, and have given, informed consent to their participation in the study.
Exclusion criteria
1. Pregnant women. 2. Immunocompromised patients. 3. Patients with a documented history of cephalosporin allergy 4. Patients with a documented history of major penicillin allergy 5. Current involvement in any other research project.
Outcome results
None listed