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Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of antibiotics in elective non-hysterectomy gynaecological laparoscopy for benign procedures
Scientific title
Antibiotic Prophylaxis in Benign Gynaecological Laparoscopic Surgery
Secondary ID [1] 293245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Gynaecological Laparoscopic Surgery 305293 0
Condition category
Condition code
Infection 304598 304598 0 0
Studies of infection and infectious agents
Surgery 304606 304606 0 0
Other surgery

Study type
Description of intervention(s) / exposure
2g intravenous Cephazolin made into a 10ml solution, given within 30min prior to the beginning of Laparoscopic Surgery
Intervention code [1] 299507 0
Intervention code [2] 299513 0
Treatment: Drugs
Comparator / control treatment
10ml injection of normal saline, given within 30min prior to the beginning of laparoscopic surgery
Control group

Primary outcome [1] 303823 0
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.
Timepoint [1] 303823 0
6 weeks post-operative
Primary outcome [2] 303833 0
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.
Timepoint [2] 303833 0
Up to 6 weeks
Secondary outcome [1] 340224 0
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
Timepoint [1] 340224 0
Within 30min post antibiotic administration
Secondary outcome [2] 340225 0
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.
Timepoint [2] 340225 0
Up to 6 weeks post-operatively
Secondary outcome [3] 340226 0
Length of hospital stay
Timepoint [3] 340226 0
Till time of discharge

Key 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.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis
All data from the Case-Report Forms will be entered into an electronic database. Data will be analysed using SPSS (v X2 SPSS Inc, Chicago Ill). Feasibility will be determined by rates of cases completed without accidental unblinding and analysis of adverse events in each group. Analysis of all primary and secondary outcome measures will be on an intention-to-treat basis although it is not expected to reach significance in this pilot trial. Demographic data will be compared using appropriate parametric and non-parametric statistical tests following the assessment of the distribution of the data by the Kolgarov-Smirnov method. Categorical data such as the presence or absence of infection will be compared using a Chi-square test with Fischer’s exact test where appropriate.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9302 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 17967 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 297874 0
Name [1] 297874 0
Australasian Gynaecological Endoscopy and Surgery Society
Address [1] 297874 0
PO Box 717
QLD 4068
Country [1] 297874 0
Primary sponsor type
Royal Hospital for Women
Barker St,
Randwick NSW 2031
Secondary sponsor category [1] 296921 0
Name [1] 296921 0
Address [1] 296921 0
Country [1] 296921 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298924 0
South Eastern Sydney Local Health District
Ethics committee address [1] 298924 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 298924 0
Date submitted for ethics approval [1] 298924 0
Approval date [1] 298924 0
Ethics approval number [1] 298924 0

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.
Trial website
No Website
Trial related presentations / publications
Public notes

Principal investigator
Name 78666 0
A/Prof Jason Abbott
Address 78666 0
Royal Hospital for Women
Barker Street, Randwick, NSW 2031
Country 78666 0
Phone 78666 0
Fax 78666 0
Email 78666 0
Contact person for public queries
Name 78667 0
A/Prof Jason Abbott
Address 78667 0
Royal Hospital for Women
Barker Street, Randwick, NSW 2031
Country 78667 0
Phone 78667 0
Fax 78667 0
Email 78667 0
Contact person for scientific queries
Name 78668 0
A/Prof Jason Abbott
Address 78668 0
Royal Hospital for Women
Barker St, Randwick, NSW 2031
Country 78668 0
Phone 78668 0
Fax 78668 0
Email 78668 0

No information has been provided regarding IPD availability
Summary results
No Results