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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Helse Midt-Norge | OTHER |
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The goal of this study is to increase knowledge about how to treat patients after sinus surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| debridement or saline irrigation | Experimental | 1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| debridement or saline irrigation | Procedure | debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adhesions in middle meatus or not | synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain due to cleaning of the nose | Pain on VAS | 1 and 2 weeks after surgery |
| Does cleaning of the nose reduce: crusts in the nose 14 days after surgery | 0=no crusts
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Sorlandet Hospital | Kristiansand | 4606 | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17075402 | Result | Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D003646 | Debridement |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 2 weeks after surgery |
| the tendency to post operative infections | Patient information connected to examination from the investigator | 3 months |
| Does debridement increase bleeding from the nose the first 14 days after surgery | 0 no bleeding
| 2 weeks |
| nasal congestion after surgery | a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery | 2 weeks |
| Trondheim |
| 7052 |
| Norway |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |