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

Phase 4

Completed

• Conditions: Benign Gynaecological Laparoscopic Surgery; Infection - Studies of infection and infectious agents; Surgery - Other surgery

• Registration Number: ACTRN12617001528347
• Lead Sponsor: Royal Hospital for Women

Brief Summary

In this study, we compared the effects of antibiotics versus a placebo for women having gynaecological surgery by laparoscopy that did not include a hysterectomy. They were followed up at 2 and 4 weeks following their surgery to determine their rates of infection. 170 patients were eligible for the study, with 117 randomly allocated to one of the two groups. We did not show a statistical difference between the groups after 6 weeks, and all other factors such as length of hospital stay, rates of readmission into hospital and medication related reactions were the same between groups. This study was to confirm whether it was feasible to perform such a study in a larger setting, and that has been confirmed. We did not expect to determine the answer to our primary research question given the small numbers. It is important to undertake a larger study to determine if antibiotics should be used prophylactically for gynaecological surgery by laparoscopy that did not include a hysterectomy, since antibiotic resistance is increasing world wide. Ensuring that this is an effective use of antibiotics is important for reducing infection in the surgical patient given that it may increase antibiotic resistance for infections that arise in other situations.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-03
• Study Completion: 2021-04-22
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 117

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified