Postoperative Treatment After Endoscopic Sinus Surgery

Kuopio University Hospital

Status: Completed

Conditions: Sinusitis

Treatments: Procedure: active debridement; Procedure: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT00534768

KUH5551813

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Active Comparator group

Description:

debridement on 1st, 3-5th and 7th postoperative days

Treatment:

Procedure: active debridement

2

Active Comparator group

Treatment:

Procedure: control group