ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619000505101

Ethics application status

Approved

Date submitted

11/03/2019

Date registered

28/03/2019

Date last updated

16/04/2021

Date data sharing statement initially provided

28/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Antibiotics in sinus surgery

Scientific title

A pilot study of post-operative antibiotics in patients undergoing Endoscopic Sinus Surgery in the treatment of Chronic Rhinosinusitis and their effect on sino-nasal outcomes

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1229-8735

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic rhinosinusitis

Condition category

Condition code

Surgery

Other surgery

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Doxycycline 100mg tablets by mouth twice daily for 4 weeks, commencing on the morning after surgery. Patients will be asked to return any unused tablets to monitor adherence.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Microcellulose placebo tablet by mouth twice daily for 4 weeks starting on the morning after surgery

Control group

Placebo

Outcomes

Primary outcome [1]

Proportional change in 22-item Sino Nasal Outcome Tool (SNOT-22) compared with pre-operative SNOT-22 score

Timepoint [1]

3 months after surgery

Secondary outcome [1]

Modified Lund Mckay Postoperative Endoscopy Score (MLMES) Reference: Snidvongs et al. Rhinology. 2013

Timepoint [1]

3 months after surgery

Secondary outcome [2]

Proportional change in 22-item Sino Nasal Outcome Tool (SNOT-22) compared with pre-operative SNOT-22 score

Timepoint [2]

12 months after surgery

Secondary outcome [3]

Change in sinus mucus microbial ecology assessing the resident microflora of sinus tissue and sinus mucus using PCR to amplify microbial DNA

Timepoint [3]

2 weeks after surgery

Secondary outcome [4]

Change in sinus mucus microbial ecology assessing the resident microflora of sinus tissue and sinus mucus using PCR to amplify microbial DNA

Timepoint [4]

3 months after surgery

Secondary outcome [5]

Patient reported adverse events including but not limited to rash, diarrhoea, vomiting, abdominal pain

Timepoint [5]

Entire time course over which study drug and placebo are administered

Eligibility

Key inclusion criteria

Patient undergoing Bilateral Comprehensive Endoscopic Sinus Surgery for the treatment of chronic rhinosinusitis as defined by the European Position Statement, 2012.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Prior sinus surgery
Predisposing condition (e.g. Aspirin exacerbated respiratory disease, Granulomatosis with Polyangitis, Cystic fibrosis)
Antibiotic usage in the 12 weeks prior to recruitment

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

This is intended as a pilot study with a view to future power analysis and a larger, definitive study

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2019

Actual

21/11/2019

Date of last participant enrolment

Anticipated

31/12/2019

Actual

1/10/2020

Date of last data collection

Anticipated

31/12/2020

Actual

23/12/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Waikato Medical Research Foundation

Address [1]

Mail: Waikato Medical Research Foundation Peter Rothwell Academic Centre Waikato Hospital Pembroke Street Private Bag 3200 Waikato Mail Centre Hamilton 3240 Email: [email protected]

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr. Andrew James Wood

Address

Department of Surgery
Waikato Clinical School
Waikato Hospital
Pembroke Street
Hamilton 3204

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr. Charles Lee

Address [1]

University of Waikato Te Whare Wananga o Waikato Gate 1, Knighton Road Hamilton 3240 Private Bag 3105 Hamilton 3240 New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC

Ethics committee address [1]

Email: hdecs@moh.govt.nz

Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

29/03/2019

Approval date [1]

01/10/2019

Ethics approval number [1]

19/NTA/64/AM01

Summary

Brief summary

Chronic rhinosinusitis (CRS) produces an enormous health burden being common, morbid and expensive. It is characterised by chronic (i.e. more than 12 weeks of) sinus and nasal inflammation causing nasal obstruction and discharge as well as facial pain / pressure and smell disruption with consequent implications for both sleep and daytime productivity. A large European study reported a prevalence of CRS of 10.9% 

The pathophysiology of CRS is a matter of significant debate and ongoing research. The Principle Investigator has previously completed a Doctoral Thesis on this topic titled “Characterising host microbe interactions in chronic rhinosinusitis”. Despite ongoing study, the role of bacteria in the disease process remains poorly understood. Observations such as that the presence of Staphylococcus aureus in the sinuses at the time of surgery is associated with worse outcomes have continued to promote hypotheses regarding pathophysiology that incorporate bacteria.

In patients with CRS, medical treatment with saline lavage and topical and systemic corticosteroids is typically recommended. In those individuals who do not respond well to these treatments, Endoscopic Sinus Surgery (ESS) is commonly offered. ESS is now one of the most commonly performed elective surgical procedures in the Western world.

The evidence to support the use of antibiotics both in the treatment of CRS and after ESS for CRS remains limited. A 2018 review of evidence-based peri-operative antibiotic use in Ear Nose and Throat Surgery documented a paucity of data in this area but concluded that "current evidence does not support the routine use of prophylactic antibiotics for endoscopic sinus surgery." The overwhelming majority of Ear Nose and Throat Surgeons when surveyed however reported that they routinely prescribe antibiotics after ESS.

Antibiotic resistance has been described by the World Health Organisation (WHO) as “one of the biggest threats to global health” and is accelerated by misuse of antibiotics. Data to rationalise or discourage the use of antibiotics are therefore urgently required.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew James Wood

Address

Department of Surgery Waikato Clinical School Waikato Hospital Pembroke Street Hamilton 3204

Country

New Zealand

Phone

+64 7 8398750

Fax

[email protected]

Contact person for public queries

Name

Andrew James Wood

Address

Department of Surgery Waikato Clinical School Waikato Hospital Pembroke Street Hamilton 3204

Country

New Zealand

Phone

+64 7 8398750

Fax

[email protected]

Contact person for scientific queries

Name

Andrew James Wood

Address

Department of Surgery Waikato Clinical School Waikato Hospital Pembroke Street Hamilton 3204

Country

New Zealand

Phone

+64 7 8398750

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Anyone that accesses the published manuscript

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified demographics, pre-operative clinical parameters, outcome measures and adverse events

What types of analyses could be done with individual participant data?

• Any

When can requests for individual participant data be made (start and end dates)?

From:
After completion of the study the intention is to publish the data in the International Scientific literature and present our findings at International Scientific meetings

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Publication in Scientific literature

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically