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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 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]

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

Condition category

Condition code

Infection

Studies of infection and infectious agents

Surgery

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]

Prevention

Intervention code [2]

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]

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]

6 weeks post-operative

Primary outcome [2]

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]

Up to 6 weeks

Secondary outcome [1]

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]

Within 30min post antibiotic administration

Secondary outcome [2]

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]

Up to 6 weeks post-operatively

Secondary outcome [3]

Length of hospital stay

Timepoint [3]

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?

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]

Royal Hospital for Women - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australasian Gynaecological Endoscopy and Surgery Society

Address [1]

PO Box 717
Indooroopilly
QLD 4068
AUSTRALIA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Hospital for Women

Address

Barker St,
Randwick NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District

Ethics committee address [1]

Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/10/2017

Approval date [1]

31/10/2017

Ethics approval number [1]

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

A/Prof Jason Abbott

Address

Royal Hospital for Women
Barker Street, Randwick, NSW 2031

Country

Australia

Phone

+61293826111

Fax

[email protected]

Contact person for public queries

Name

Jason Abbott

Address

Royal Hospital for Women
Barker Street, Randwick, NSW 2031

Country

Australia

Phone

+61293826111

Fax

[email protected]

Contact person for scientific queries

Name

Jason Abbott

Address

Royal Hospital for Women
Barker St, Randwick, NSW 2031

Country

Australia

Phone

+61293826111

Fax

[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.	Type	Email
13848	Study protocol	[email protected]
13849	Statistical analysis plan	[email protected]
13850	Ethical approval	[email protected]
13851	Informed consent form	[email protected]

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.

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