Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT00184392
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?
Sponsor:
Norwegian University of Science and Technology
Organization:
Study Overview
Official Title:
Debridement After Functional Endoscopic Sinus Surgery
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to increase knowledge about how to treat patients after sinus surgery.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: