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This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.
Methods:
A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silastic group | Active Comparator | included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint |
|
| Quilting group | Active Comparator | included patients who underwent septoplasty followed by quilting suture (Septal through and through suture) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septoplasty surgery | Procedure | septoplasty procedures were performed by a single surgeon using the same technique among all patients. The procedures were conducted under general anesthesia according to the standard preoperative care used in our institution. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NOSE score 1 month postoperatively | NOSE change = preoperative NOSE - 1 month postoperative NOSE | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Validated NOSE score | NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively | |
| complications | Bleeding, Bad smell, Synechia, Crustation and Perforation | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City | Riyadh | 14611 | Saudi Arabia |
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| postoperative pain | using numerical Pain scale (0 to 10) | at 3 days postoperative |
| general satisfaction questionnaire | at 1 month postoperative |