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Trial registered on ANZCTR


Registration number
ACTRN12617001528347
Ethics application status
Approved
Date submitted
31/10/2017
Date registered
3/11/2017
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
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)
U1111-1204-4989
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

Intervention/exposure
Study type
Interventional
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
Prevention
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
Placebo

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
No
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
Prevention
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2019
Actual
21/02/2019
Date of last participant enrolment
Anticipated
6/11/2019
Actual
16/03/2021
Date of last data collection
Anticipated
20/12/2020
Actual
22/04/2021
Sample size
Target
150
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
NSW
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
Charities/Societies/Foundations
Name [1] 297874 0
Australasian Gynaecological Endoscopy and Surgery Society
Country [1] 297874 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Barker St,
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 296921 0
None
Name [1] 296921 0
Address [1] 296921 0
Country [1] 296921 0

Ethics approval
Ethics application status
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
Australia
Date submitted for ethics approval [1] 298924 0
09/10/2017
Approval date [1] 298924 0
31/10/2017
Ethics approval number [1] 298924 0

Summary
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
Nil
Public notes
Nil

Contacts
Principal investigator
Name 78666 0
A/Prof Jason Abbott
Address 78666 0
Royal Hospital for Women
Barker Street, Randwick, NSW 2031
Country 78666 0
Australia
Phone 78666 0
+61293826111
Fax 78666 0
Email 78666 0
[email protected]
Contact person for public queries
Name 78667 0
Jason Abbott
Address 78667 0
Royal Hospital for Women
Barker Street, Randwick, NSW 2031
Country 78667 0
Australia
Phone 78667 0
+61293826111
Fax 78667 0
Email 78667 0
[email protected]
Contact person for scientific queries
Name 78668 0
Jason Abbott
Address 78668 0
Royal Hospital for Women
Barker St, Randwick, NSW 2031
Country 78668 0
Australia
Phone 78668 0
+61293826111
Fax 78668 0
Email 78668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outcome data (deidentified).
When will data be available (start and end dates)?
September 30th 2021 start - September 30th 2026
Available to whom?
Researchers for meta-analyses. Scientific validation
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
To be updated once data repository link finalised


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13848Study protocol  [email protected]
13849Statistical analysis plan  [email protected]
13850Ethical approval  [email protected]
13851Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373902-(Uploaded-12-07-2021-16-53-56)-Basic results summary.docx
Plain language summaryNo In this study, we compared the effects of antibiot... [More Details]

Documents added automatically
No additional documents have been identified.