Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001438549
Ethics application status
Approved
Date submitted
19/06/2024
Date registered
11/12/2024
Date last updated
11/12/2024
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgical Antibiotic Prophylaxis in Gynaecological Laparoscopic Surgery: A Multi-Centre Randomised Double-Blind Placebo Controlled Trial
Scientific title
Surgical Antibiotic Prophylaxis in people undergoing Gynaecological Laparoscopic Surgery for benign conditions: A Multi-Centre Randomised Double-Blind Placebo Controlled Trial
Secondary ID [1] 312368 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection 334160 0
Condition category
Condition code
Infection 330894 330894 0 0
Other infectious diseases
Surgery 330830 330830 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this trial are those planning to undergo elective gynaecological laparoscopic surgery for benign conditions that are low risk of breach to bladder, bowel, uterine or vaginal cavities.
Participants will be randomised to receive surgical antibiotic prophylaxis or placebo in a 1:1 ratio. The trial drug will then be administered as follows. Participants assigned to antibiotic prophylaxis will receive:
• 2 grams intravenous Cefazolin reconstituted with water for injection to a total volume of 10 mililiters within 60 minutes (ideally 15-30 minutes) before surgical incision.
• If the participant weighs >120 kilograms, a dose of 3 grams intravenous Cefazolin will be administered
Participants assigned to placebo will receive:
• 10 mililiters intravenous Normal Saline within 60 minutes (ideally 15-30 minutes) before surgical incision with a repeated dose if procedure >3 hours
If the procedure is prolonged, then a second dose of the trial drug (either Cefazolin or placebo) may be administered 4 hours from the previous dose.
The study team will complete the study operation data sheet which will include time of study test drug treatment administration, time of skin incision, length of operation, operative findings and procedures and any complications.
All patients will be followed up post operatively at two points in time:
1. The “one week” follow up: 5-8 days after surgery participants will be reviewed by a doctor in the outpatient’s clinic. The assessing doctor will be blinded to the allocation of antibiotics or placebo intraoperatively. The doctor will assess for evidence of surgical site infection and collect appropriate samples when indicated to help clarify the diagnosis of surgical site infection.
2. The “four week” follow up: 25-32 days after surgery participants will attend their routine post-operative review appointment with a doctor. The assessing doctor will be blinded to the allocation of antibiotics or placebo intraoperatively.



Intervention code [1] 328868 0
Treatment: Drugs
Comparator / control treatment
Participants randomised to receive placebo will receive 10 millilitres of normal saline intravenous pre-operatively
Control group
Placebo

Outcomes
Primary outcome [1] 338598 0
To compare the odds of all surgical site infection in benign gynaecological laparoscopy between those who receive prophylactic antibiotics versus placebo
Timepoint [1] 338598 0
Surgical site infection for gynaecological procedures is defined as infection up to 30 days post procedure. Participants will be assessed at 1 weeks and 4 weeks post procedure for signs of infection where a clinical assessment and further investigation (cultures, imaging) can be arranged. Any unscheduled presentations will also be recorded and a letter provided to the participant in the event they present with symptoms of infection to the GP or another health service within the 30 day time period.
Secondary outcome [1] 436849 0
Deep incisional surgical site infection (SSI)
Timepoint [1] 436849 0
Surgical site infection for gynaecological procedures is defined as infection up to 30 days post procedure. Participants will be assessed at 1 weeks and 4 weeks post procedure for signs of infection where a clinical assessment and further investigation (cultures, imaging) can be arranged. Any unscheduled presentations will also be recorded and a letter provided to the participant in the event they present with symptoms of infection to the GP or another health service within the 30 day time period.
Secondary outcome [2] 436534 0
Superficial incisional surgical site infection (SSI)
Timepoint [2] 436534 0
Surgical site infection for gynaecological procedures is defined as infection up to 30 days post procedure. Participants will be assessed at 1 weeks and 4 weeks post procedure for signs of infection where a clinical assessment and further investigation (cultures, imaging) can be arranged. Any unscheduled presentations will also be recorded and a letter provided to the participant in the event they present with symptoms of infection to the GP or another health service within the 30 day time period.
Secondary outcome [3] 442517 0
Organ/space surgical site infection (SSI)
Timepoint [3] 442517 0
Surgical site infection for gynaecological procedures is defined as infection up to 30 days post procedure. Participants will be assessed at 1 weeks and 4 weeks post procedure for signs of infection where a clinical assessment and further investigation (cultures, imaging) can be arranged. Any unscheduled presentations will also be recorded and a letter provided to the participant in the event they present with symptoms of infection to the GP or another health service within the 30 day time period.

Eligibility
Key inclusion criteria
• Age 18 years or above
• Planned laparoscopy for investigation and treatment of benign gynaecological disorders
• Patient consent
• For Australian sites: English speakers
• For Israeli sites: Hebrew or English speakers
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• High suspicion of malignancy
• Planned or high risk of breach of bladder/bowel/uterine/vaginal cavity
o Hysterectomy
o Myomectomy where breach of the endometrial cavity is predicted
o Planned rectal shave, disc or segmental resection
o Planned bladder resection or ureteric anastomosis
• Allergy or contraindication to receive cefazolin. Contraindication to cefazolin includes patients with immediate hypersensitivity reactions to penicillins (eg urticarial, angio-oedema, bronchospasm, anaphylaxis) and/or history of adverse reaction to cefazolin.
• Indication for the use of surgical antibiotic prophylaxis (such as mechanical heart valve or other prosthesis requiring surgical antibiotic prophylaxis, immunocompromised patient)
• Infection present at time of surgery (PATOS): Evidence of infection at or adjacent to operative site before surgery (including current skin infection on abdominal wall, urinary tract infection, pelvic inflammatory disease, endometritis)
• Emergency laparoscopies
• Pregnancy

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)
Following enrolment to the trial, the research team will inform the anaesthetic team providing them with the opaque allocation envelope marked with the participant’s unique study number and drug allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by a statistician (SF) who has no subject contact, using a random number generator with variable size blocking (size=4, 6 or 8). These will be used to produce sequentially numbered opaque envelopes containing a sheet indicating the treatment arm (placebo or antibiotic) that will be provided to the anaesthetic team.
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data analysis will be performed by a statistician. This study will be analysed on an “intention to treat” basis. Measures will be summarised as proportions for binary variables and means (standard deviation) or median (interquartile range) for continuous variables. The effect of treatment on all types of SSI will be analysed using logistic regression, given the outcome is binary; the treatment effect will be quantified with an odds ratio (treatment/control) plus a 95% confidence interval and 2-sided p-value. The same analysis will be undertaken for the other binary outcomes. Multiple imputations will be used to account for any missing data. Subgroup analysis of the same SSI outcomes will be performed across each site.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
4/01/2027
Actual
Date of last data collection
Anticipated
8/02/2027
Actual
Sample size
Target
618
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 26389 0
Israel
State/province [1] 26389 0

Funding & Sponsors
Funding source category [1] 316776 0
Self funded/Unfunded
Name [1] 316776 0
Country [1] 316776 0
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 318995 0
None
Name [1] 318995 0
Address [1] 318995 0
Country [1] 318995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315545 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315545 0
Ethics committee country [1] 315545 0
Australia
Date submitted for ethics approval [1] 315545 0
02/07/2024
Approval date [1] 315545 0
22/10/2024
Ethics approval number [1] 315545 0
HREC/108853/MH-2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135034 0
Dr Lucy Richards
Address 135034 0
c/o The Royal Women's Hospital, 20 Flemington Rd, Parkville, VIC 3052
Country 135034 0
Australia
Phone 135034 0
+61417427424
Fax 135034 0
Email 135034 0
[email protected]
Contact person for public queries
Name 135035 0
Lucy Richards
Address 135035 0
c/o The Royal Women's Hospital, 20 Flemington Rd, Parkville, VIC 3052
Country 135035 0
Australia
Phone 135035 0
+613 8345 2000
Fax 135035 0
Email 135035 0
[email protected]
Contact person for scientific queries
Name 135036 0
Lucy Richards
Address 135036 0
c/o The Royal Women's Hospital, 20 Flemington Rd, Parkville, VIC 3052
Country 135036 0
Australia
Phone 135036 0
+613 8345 2000
Fax 135036 0
Email 135036 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.