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Sponsored by: |
Kuopio University Hospital |
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Information provided by: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00534768 |
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.
Condition | Intervention |
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Sinusitis |
Procedure: active debridement Procedure: control group |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Postoperative Treatment After Endoscopic Sinus Surgery |
Study Start Date: | January 2003 |
Arms | Assigned Interventions |
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1: Active Comparator
debridement on 1st, 3-5th and 7th postoperative days
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Procedure: active debridement
debridement on 1st, 3-5th and 7th postoperative days
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2: Active Comparator |
Procedure: control group
Postoperative debridement on 7th postoperative day
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
The patients were excluded if they had:
Other exclusion criteria were pregnancy and ongoing anticoagulant therapy.
Finland | |
Kuopio University Hospital | |
Kuopio, Finland |
Principal Investigator: | Tatu p Kemppainen, MD | Kuopio University Hospital |
Study Director: | Juhani Nuutinen, PhD | Kuopio University |
Study ID Numbers: | KUH5551813 |
Study First Received: | September 24, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00534768 History of Changes |
Health Authority: | Finland: Ethics Committee; Finland: National Agency for Medicines |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Sinusitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Paranasal Sinus Diseases Sinusitis Nose Diseases |