None listed
Conditions
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.
Interventions
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
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.
Sponsors
Aristotle Univeristy of Thessaloniki
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed