Acute Recurrent Rhinosinusitis
Conditions
Keywords
Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps, Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps
Brief summary
The goal of this study is to increase knowledge about how to treat patients after sinus surgery.
Detailed description
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.
Interventions
PROCEDUREdebridement or saline irrigation
debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery
Sponsors
St. Olavs Hospital
Helse Midt-Norge
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesions in middle meatus or not | 3 months | synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain due to cleaning of the nose | 1 and 2 weeks after surgery | Pain on VAS |
| Does cleaning of the nose reduce: crusts in the nose 14 days after surgery | 2 weeks after surgery | 0=no crusts 1. =mild 2. =impossible to see under concha media |
| the tendency to post operative infections | 3 months | Patient information connected to examination from the investigator |
| Does debridement increase bleeding from the nose the first 14 days after surgery | 2 weeks | 0 no bleeding 1. spots of blood 2. bleeding from the nose |
| nasal congestion after surgery | 2 weeks | a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery |
Countries
Norway
Outcome results
None listed