Septoplasty
Conditions
Keywords
Intranasal splint, Silastic sheet, quilting suture, NOSE score
Brief summary
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.
Interventions
PROCEDURESeptoplasty surgery
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.
Sponsors
King Abdulaziz Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.
Exclusion criteria
* 1\. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NOSE score 1 month postoperatively | 1 month postoperatively | NOSE change = preoperative NOSE - 1 month postoperative NOSE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated NOSE score | NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively | — |
| complications | 1 month | Bleeding, Bad smell, Synechia, Crustation and Perforation |
| postoperative pain | at 3 days postoperative | using numerical Pain scale (0 to 10) |
| general satisfaction questionnaire | at 1 month postoperative | — |
Countries
Saudi Arabia
Outcome results
None listed