Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?

Study Overview
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Brief Summary
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The goal of this study is to increase knowledge about how to treat patients after sinus surgery.

Detailed Description
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Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation. Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.

Official Title
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Debridement After Functional Endoscopic Sinus Surgery

Conditions
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Acute Recurrent Rhinosinusitis

Intervention / Treatment
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* Procedure: debridement or saline irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy. Exclusion Criteria: Previous FESS Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid) Primary ciliary dyskinesia Pregnancy Septoplasty in the same surgery Ongoing treatment for cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: debridement or saline irrigation<br>1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation | Procedure: debridement or saline irrigation<br>* debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesions in middle meatus or not | synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to cleaning of the nose | Pain on VAS | 1 and 2 weeks after surgery | 
| Does cleaning of the nose reduce: crusts in the nose 14 days after surgery | 0=no crusts =mild =impossible to see under concha media | 2 weeks after surgery | 
| the tendency to post operative infections | Patient information connected to examination from the investigator | 3 months | 
| Does debridement increase bleeding from the nose the first 14 days after surgery | 0 no bleeding spots of blood bleeding from the nose | 2 weeks | 
| nasal congestion after surgery | a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps, Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps