NCT00534768

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

First QC Date

September 24, 2007

Last Update Submit

January 11, 2008

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • scarring in middle meatus 4 weeks after ESS

    4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

debridement on 1st, 3-5th and 7th postoperative days

Procedure: active debridement

2

ACTIVE COMPARATOR
Procedure: control group

Interventions

active debridementPROCEDURE

debridement on 1st, 3-5th and 7th postoperative days

1
control groupPROCEDURE

Postoperative debridement on 7th postoperative day

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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; }}

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tatu p Kemppainen, MD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

  • Juhani Nuutinen, PhD

    Kuopio University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

January 1, 2003

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

FI(1)