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

Norwegian University of Science and Technology

Status: Completed

Conditions: Acute Recurrent Rhinosinusitis

Treatments: Procedure: debridement or saline irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT00184392

229-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 1 patient group

debridement or saline irrigation

Experimental group

Description:

1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation

Treatment:

Procedure: debridement or saline irrigation