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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
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

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

First Posted
September 24, 2007
Last Updated
January 11, 2008
Sponsor
Kuopio University Hospital
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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

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Postoperative Treatment After Endoscopic Sinus Surgery

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