Postoperative Treatment After Endoscopic Sinus Surgery

NCT ID: NCT00534768

Last Updated: 2008-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Brief Summary

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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

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Conditions

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

active debridement

Intervention Type PROCEDURE

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

2

Group Type ACTIVE_COMPARATOR

control group

Intervention Type PROCEDURE

Postoperative debridement on 7th postoperative day

Interventions

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active debridement

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

Intervention Type PROCEDURE

control group

Postoperative debridement on 7th postoperative day

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Tatu p Kemppainen, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Juhani Nuutinen, PhD

Role: STUDY_DIRECTOR

Kuopio University

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5551813

Identifier Type: -

Identifier Source: org_study_id

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