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Postoperative Treatment After Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534768
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : January 14, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sinusitis Procedure: active debridement Procedure: control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Treatment After Endoscopic Sinus Surgery
Study Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Sinusitis

Arm Intervention/treatment
Active Comparator: 1
debridement on 1st, 3-5th and 7th postoperative days
Procedure: active debridement
debridement on 1st, 3-5th and 7th postoperative days

Active Comparator: 2 Procedure: control group
Postoperative debridement on 7th postoperative day

Primary Outcome Measures :
  1. scarring in middle meatus 4 weeks after ESS [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534768

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Kuopio University Hospital
Kuopio, Finland
Sponsors and Collaborators
Kuopio University Hospital
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Principal Investigator: Tatu p Kemppainen, MD Kuopio University Hospital
Study Director: Juhani Nuutinen, PhD Kuopio University
Layout table for additonal information Identifier: NCT00534768    
Other Study ID Numbers: KUH5551813
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases