Clinical trial NCT00184392: Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?
Official title: Debridement After Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Recurrent Rhinosinusitis
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
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Midt-Norge
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adhesions in middle meatus or not
timeFrame: 3 months
Secondary outcomes:
measure: Pain due to cleaning of the nose
timeFrame: 1 and 2 weeks after surgery
measure: Does cleaning of the nose reduce: crusts in the nose 14 days after surgery
timeFrame: 2 weeks after surgery
measure: the tendency to post operative infections
timeFrame: 3 months
measure: Does debridement increase bleeding from the nose the first 14 days after surgery
timeFrame: 2 weeks
measure: nasal congestion after surgery
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Department of Otolaryngology, Sorlandet Hospital
city: Trondheim
country: Norway
facility: Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
Study officials:
affiliation: Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
name: Vegard Bugten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.