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Trial registered on ANZCTR


Registration number
ACTRN12621000691842
Ethics application status
Approved
Date submitted
3/05/2020
Date registered
7/06/2021
Date last updated
21/07/2024
Date data sharing statement initially provided
7/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized, controlled study of the effect of local and systemic factors on the postoperative course of patients with chronic rhinosinusitis (CRS) who underwent functional endoscopic sinus surgery (FESS).
Scientific title
Randomized, controlled study of the effect of local and systemic factors on the postoperative course of patients with chronic rhinosinusitis (CRS) who underwent functional endoscopic sinus surgery (FESS).
Secondary ID [1] 301180 0
None
Universal Trial Number (UTN)
U1111-1251-3778
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis 317315 0
Condition category
Condition code
Respiratory 315434 315434 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: patients undergoing FESS and randomly allocated to arm 1, will receive postoperatively intranasal mastic oil solution, subsequently to nasal douching and budesonide nasal spray. Nasal douching will be performed with Neilmed Sinus Rinse twice a day, followed by application of budesonide nasal spray (100 mcg/dose) sprayed in each nostril twice daily (TDD 400 mcg). Subsequently, fifteen minutes later, patients in the lateral head low (LHL or Ragan) position will apply 3 drops of mastic oil 1% solution in each nostril twice a day. Mastic oil solution will be applicable until first postoperative month. Henceforth, patients will continue their therapy with nasal douching and budesonide nasal spray for another month. Face-to-face adherence reminder sessions will take place before discharge from the hospital and at each study visit thereafter. This session will include:
The importance of following study guidelines.
Importance of calling the clinic if experiencing problems possibly related to study product.
Arm 2: Face-to-face adherence reminder sessions will take place before discharge from the hospital and at each study visit thereafter. This session will include:
The importance of following study guidelines.
Importance of calling the clinic if experiencing problems possibly related to study product
patients undergoing FESS and randomly allocated to arm 2, will receive postoperatively budesonide by means of nasal nebulization. PARI SINUS (PARI GmbH) nebulizer, that causes the aerosol to pulsate so that it can penetrate the sinus cavities will be provided to patients on arm 2. Patients will apply a Budesonide suspension for inhalation (0.5 mg/2 mL) into the nebulizer upper chamber. Treatment for each nostril will last for 2.5 minutes, twice a day. Treatment shall be completed after two months.
Face-to-face adherence reminder sessions will take place before discharge from the hospital and at each study visit thereafter. This session will include:The importance of following study guidelines.Importance of calling the clinic if experiencing problems possibly related to study product.
Arm 3: patients undergoing FESS and randomly allocated to arm 3, will receive postoperatively oral doxycycline additionally to nasal douching and budesonide nasal spray. Nasal douching will be performed with Neilmed Sinus Rinse twice a day, followed by application of budesonide nasal spray (100 mcg/dose) sprayed in each nostril twice daily (TDD 400 mcg). Additionally, following the first postoperative week, patients will receive doxycycline 200 mg on day 1, followed by 100 mg daily until 56 days post-operatively.
Face-to-face adherence reminder sessions will take place before discharge from the hospital and at each study visit thereafter. This session will include:
The importance of following study guidelines.
Instructions about taking study pills including dose timing, storage, and importance of taking pills whole, and what to do in the event of a missed dose.
Notification that there will be a pill count at every study visit.
Importance of calling the clinic if experiencing problems possibly related to study product.
Intervention code [1] 317487 0
Treatment: Drugs
Intervention code [2] 317488 0
Treatment: Devices
Comparator / control treatment
Control group patients will perform nasal douching twice a day using Neilmed Sinus Rinse, apply budesonide nasal spray (100 mcg/dose), sprayed in each nostril twice daily (TDD 400 mcg) and receive a short course of oral cefuroxime (500 mg twice a day for 7 days). Both nasal douching and application of nasal spray will last for two months.
Face-to-face adherence reminder sessions will take place before discharge from the hospital and at each study visit thereafter. This session will include:
The importance of following study guidelines.
Importance of calling the clinic if experiencing problems possibly related to study product.
Control group
Active

Outcomes
Primary outcome [1] 323683 0
The primary outcome was change in SNOT-22 score 2 months after surgery. Patients were categorized according to baseline SNOT-22 score, and the proportion of patients achieving a SNOT-22 minimal clinically important difference (MCID) of 8.9 was calculated, as well as the percentage change in SNOT-22 score.
Timepoint [1] 323683 0
Baseline, 1st month, 2nd month (primary timepoint, 6th month.
Primary outcome [2] 323684 0
Primary outcome 2 was change in Lund-Kennedy endoscopic score 2 months after surgery. Patients were categorized according to baseline Lund-Kennedy score and the percentage change on the first, second and sixth month.
Timepoint [2] 323684 0
Baseline, 1st month, 2nd month (primary timepoint), 6th month.
Primary outcome [3] 323685 0
Another primary outcome was change in Lund-Mackay radiological score in CT 6 months after surgery. Patients were categorized according to baseline Lund-Mackay score and the percentage change on the sixth month.
Timepoint [3] 323685 0
Baseline, 6th month (primary timepoint)
Secondary outcome [1] 382565 0
A secondary outcome was change in Global Osteitis Scoring Scale in CT 6 moths after surgery. Patients were categorized according to baseline GOSS score and the percentage change on the sixth month.
Timepoint [1] 382565 0
0 and 6th month
Secondary outcome [2] 382566 0
Secondary outcome 2 was the absolute number of appointments needed, postoperatively, for debridement of the nasal cavity and VAS score for patient’s discomfort during debridement.
Timepoint [2] 382566 0
0, 1st, 2nd, 3rd, 4th, 8th week

Eligibility
Key inclusion criteria
Patients were at least 18 years old, diagnosed with CRS with or without nasal polyposis (EPOS) and scheduled for bilateral functional endonasal endoscopic sinus surgery (FESS) or bilateral revision FESS. Patients with cystic fibrosis, immunodeficiencies, mucociliary dysfunction, fungal balls, systemic vasculitis, granulomatous diseases or cocaine abuse were excluded. The indication for surgery was made when medical treatment as recommended by the EPOS treatment algorithms failed, including saline irrigations, nasal corticosteroids, and one or more courses with oral treatment with oral corticosteroids and/or antibiotics. Nasal corticosteroids were stopped one week before surgery. Systemic corticosteroid drugs were stopped for at least one month before surgery.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following are defined as exclusion criteria for patients:
Immunotherapy, decongestants (oral or nasal), cromolyns, ipatropium bromide, montelukast and monoclonal antibodies were prohibited before and during the study.
history of recent upper respiratory infection or exacerbation of chronic rhinosinusitis up to 3 weeks before surgery.
Chronic steroid intake for any reason other than chronic rhinosinusitis.
Medical history of head and neck cancer and radiotherapy in the head area.
Medical history of substance abuse or alcohol.
Hypersensitivity to doxycycline.
Taking other medications that could affect doxycycline intake.
Patients with known severe liver, kidney, skin or GI disease.

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 by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Random Allocation Software v 1.0
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined based on the mean improvement value of clinical significance of SNOT-22 and endoscopic and imaging staging with Lund-Kennedy and Lund-Mackay systems respectively. For the questionnaire the difference with clinical significance is 8.9 with standard deviation (SD) 2.2 while for Lund – Kennedy and Lund-Mackay it is 2, with (SD) 1.5. Based on the above, in the normogram of Douglas Altman and for study strength at the level of 80% and acceptable type A error: 0.05, acceptable type B error: 0.10, 22 patients are needed for each part of the research.
The analysis will be performed using the statistical package SPSS for Windows, version 23, (Chicago, IL). The data will be expressed as mean ± SD. P values P <0.05 will be considered statistically significant. Parametric tests such as paired t test, two-sample t test, and variance analysis (ANOVA) will be applied to data that follow a normal distribution. Non-parametric tests such as the Mann-Whitney U test, Wilcoxon signed rank test, Sign test, chi-square test and Kruskal-Wallis test will be applied to data that do not follow a normal distribution.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/05/2020
Date of last participant enrolment
Anticipated
30/09/2021
Actual
28/06/2024
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
88
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 22527 0
Greece
State/province [1] 22527 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 305630 0
Self funded/Unfunded
Name [1] 305630 0
Panagiotis Pyriochos
Country [1] 305630 0
Greece
Primary sponsor type
University
Name
Aristotle Univeristy of Thessaloniki
Address
Aristotle University of Thessaloniki, University Campus, 54124,Thessaloniki, Greece
Country
Greece
Secondary sponsor category [1] 306037 0
Individual
Name [1] 306037 0
Iordanis Konstantinidis
Address [1] 306037 0
Iordanis Konstantinidis, Assoc. Professor in Otorhinolaryngology, Papageorgiou General Hospital, Periferiaki Odos, 56403, Thessaloniki
Country [1] 306037 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305919 0
3rd Sanitary District of Macedonia
Ethics committee address [1] 305919 0
16 Aristotelous str, 54623, Thessaloniki, Greece
Ethics committee country [1] 305919 0
Greece
Date submitted for ethics approval [1] 305919 0
11/12/2018
Approval date [1] 305919 0
17/12/2018
Ethics approval number [1] 305919 0
3ß/49441/17-12-2018

Summary
Brief summary
Functional endoscopic sinus surgery is a frequently performed procedure in chronic rhinosinusitis (CRS). Application of local or systemic factors that can improve the postoperative course of patients and reduce the recurrence rates is an area of great interest. This three – armed randomized, controlled study focuses on the effect of local and systemic factors on the postoperative course of patients with chronic rhinosinusitis (CRS) who underwent functional endoscopic sinus surgery (FESS).
On the first arm, patients undergoing FESS, will postoperatively receive intranasal mastic oil solution, subsequently to nasal douching and budesonide nasal spray.
On the second arm, patients undergoing FESS, will postoperatively receive budesonide by means of nasal nebulization.
On the third arm, patients undergoing FESS, will postoperatively receive oral doxycycline additionally to nasal douching and budesonide nasal spray.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102062 0
Dr Pyriochos Panagiotis
Address 102062 0
ENT clinic, Papageorgiou General Hospital, Periferiaki str, N. Eukarpia,56403, Thessloniki, Greece
Country 102062 0
Greece
Phone 102062 0
+302313323000
Fax 102062 0
Email 102062 0
[email protected]
Contact person for public queries
Name 102063 0
Iordanis Konstantinidis
Address 102063 0
ENT clinic, Papageorgiou General Hospital, Periferiaki str, N. Eukarpia,56403, Thessloniki, Greece
Country 102063 0
Greece
Phone 102063 0
+306973229525
Fax 102063 0
Email 102063 0
[email protected]
Contact person for scientific queries
Name 102064 0
Iordanis Konstantinidis
Address 102064 0
ENT clinic, Papageorgiou General Hospital, Periferiaki str, N. Eukarpia,56403, Thessloniki, Greece
Country 102064 0
Greece
Phone 102064 0
+306973229525
Fax 102064 0
Email 102064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned.


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.