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Postoperative Treatment After Endoscopic Sinus Surgery
This study has been completed.
First Received: September 24, 2007   Last Updated: January 11, 2008   History of Changes
Sponsored by: Kuopio University Hospital
Information provided by: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00534768
  Purpose

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
Sinusitis
Procedure: active debridement
Procedure: control group

MedlinePlus related topics: Endoscopy Sinusitis Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Postoperative Treatment After Endoscopic Sinus Surgery

Further study details as provided by Kuopio University Hospital:

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

Study Start Date: January 2003
Arms Assigned Interventions
1: Active Comparator
debridement on 1st, 3-5th and 7th postoperative days
Procedure: active debridement
debridement on 1st, 3-5th and 7th postoperative days
2: Active Comparator Procedure: control group
Postoperative debridement on 7th postoperative day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534768

Locations
Finland
Kuopio University Hospital
Kuopio, Finland
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Principal Investigator: Tatu p Kemppainen, MD Kuopio University Hospital
Study Director: Juhani Nuutinen, PhD Kuopio University
  More Information

No publications provided

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

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Sinusitis

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Paranasal Sinus Diseases
Sinusitis
Nose Diseases

ClinicalTrials.gov processed this record on May 07, 2009