Postoperative Treatment After Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00534768
First received: September 24, 2007
Last updated: January 11, 2008
Last verified: January 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Treatment After Endoscopic Sinus Surgery

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00534768     History of Changes
Other Study ID Numbers: KUH5551813
Study First Received: September 24, 2007
Last Updated: January 11, 2008
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on August 28, 2014