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Sponsors and Collaborators: |
Norwegian University of Science and Technology St. Olavs Hospital Helse midt Norge |
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Information provided by: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00184392 |
The goal of this study is to increase knowledge about how to treat patients after sinus surgery.
Condition | Intervention |
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Acute Recurrent Rhinosinusitis |
Procedure: Cleaning/debridement of the nose (or not) after sinus surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Debridement After Functional Endoscopic Sinus Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2010 |
Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.
Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway | |
Trondheim, Norway, 7052 | |
Department of Otolaryngology, Sorlandet Hospital | |
Kristiansand, Norway, 4606 |
Principal Investigator: | Vegard Bugten, M.D. | Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway |
Study ID Numbers: | 229-04 |
Study First Received: | September 15, 2005 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00184392 |
Health Authority: | Norway: Norwegian Social Science Data Services |
Sinus surgery endoscopic postoperative care debridement randomized |
acute recurrent rhinosinusitis chronic rhinosinusitis nasal polyps Chronic rhinosinusitis with nasal polyps Chronic rhinosinusitis without nasal polyps |
Nasal Polyps Polyps Recurrence |