Study Results
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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COMPLETED
NA
INTERVENTIONAL
2003-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
debridement on 1st, 3-5th and 7th postoperative days
active debridement
debridement on 1st, 3-5th and 7th postoperative days
2
control group
Postoperative debridement on 7th postoperative day
Interventions
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active debridement
debridement on 1st, 3-5th and 7th postoperative days
control group
Postoperative debridement on 7th postoperative day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Kuopio University Hospital
OTHER
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
Countries
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Other Identifiers
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KUH5551813
Identifier Type: -
Identifier Source: org_study_id
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