The use of antibiotics in elective non-hysterectomy gynaecological laparoscopy for benign procedures

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: 2g intravenous Cephazolin made into a 10ml solution, given within 30min prior to the beginning of Laparoscopic Surgery CONDITION: Benign Gynaecological Laparoscopic Surgery PRIMARY OUTCOME: Study feasibility. This will be assessed by recruitment rates of potential research participants, the rates of unblinding of treatment allocation to the patient or treating team, and rates of follow‐up at 6 weeks post‐partum. The post‐operative infections rates. Patients will be encouraged to seek assistance if any concerns about an infection. Surgical site infection will be diagnosed clinically by the treating team or a primary care doctor (e.g. general practitioner or emergency physician) although wound swabs are encouraged to confirm diagnosis and type of bacteria. SECONDARY OUTCOME: Antibiotic related reactions. These will be identified clinically at the time of surgery as anaphylaxis or skin reactions such as urticaria, rash, exanthem and pruritis ; Length of hospital stay Re‐admission to hospital. Patients will be provided with a letter of participation which will include the participant number and contact details for the research team. The letter will ask that treating doctors contact the surgical team directly if any infection occurs requiring admission to hospital. For suspected infections not requiring admission to hospital, treating doctors will be requested to provide a discharge or summary letter from the consultation to bring to their 6 week appointment. 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.
Epistemonikos ID: 94bde45872de258e87caed4b3a997630b96b15cd
First added on: Aug 25, 2024