Postoperative Treatment After Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Procedure: control group; Procedure: active debridement

• Registration Number: NCT00534768
• Lead Sponsor: Kuopio University Hospital

Brief Summary

Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated.

Study Design: Open, prospective, randomized, controlled clinical trial with two parallel groups.

Methods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study.
• The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }}

Exclusion Criteria

The patients were excluded if they had:

• Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification)
• Hemorrhagic diathesis
• Liver or kidney dysfunction
• Chronic malnutrition
• Alcoholism or inflammatory bowel disease.

Other exclusion criteria were pregnancy and ongoing anticoagulant therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	control group	-
1	active debridement	debridement on 1st, 3-5th and 7th postoperative days

Primary Outcome Measures

Name	Time	Method
scarring in middle meatus 4 weeks after ESS	4 weeks

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland