Debridement After Functional Endoscopic Sinus Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Adhesions in middle meatus or not
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
debridement or saline irrigation
1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation
Intervention: debridement or saline irrigation (Procedure)
Outcomes
Primary Outcomes
Adhesions in middle meatus or not
Time Frame: 3 months
synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present
Secondary Outcomes
- Pain due to cleaning of the nose(1 and 2 weeks after surgery)
- nasal congestion after surgery(2 weeks)
- Does cleaning of the nose reduce: crusts in the nose 14 days after surgery(2 weeks after surgery)
- the tendency to post operative infections(3 months)
- Does debridement increase bleeding from the nose the first 14 days after surgery(2 weeks)