Postoperative Treatment After Endoscopic Sinus Surgery
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
active debridement
control group
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis
Eligibility Criteria
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.
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
debridement on 1st, 3-5th and 7th postoperative days
Outcomes
Primary Outcome Measures
scarring in middle meatus 4 weeks after ESS
Secondary Outcome Measures
Full Information
NCT ID
NCT00534768
First Posted
September 24, 2007
Last Updated
January 11, 2008
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00534768
Brief Title
Postoperative Treatment After Endoscopic Sinus Surgery
Official Title
Postoperative Treatment After Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kuopio University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
debridement on 1st, 3-5th and 7th postoperative days
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
active debridement
Intervention Description
debridement on 1st, 3-5th and 7th postoperative days
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
Postoperative debridement on 7th postoperative day
Primary Outcome Measure Information:
Title
scarring in middle meatus 4 weeks after ESS
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatu p Kemppainen, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juhani Nuutinen, PhD
Organizational Affiliation
Kuopio University
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Postoperative Treatment After Endoscopic Sinus Surgery
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