N/A
Completed N=16
Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty
Source: ClinicalTrials.gov NCT01541839 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Operative Time — 35; 423 seconds
Summary
The primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty.
The secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operative Time |
35; 423 | — |
| SECONDARY Subjective Function |
2; 3 | — |
| SECONDARY Post-operative Complications |
1; 1 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- primary septoplasty
- age>18
- septal deviation
- ability to read and communicate in English
- absence of allergic rhinitis
- non-smoker
Exclusion Criteria
- revision septoplasty
- age <18
- concurrent sinusitis or endoscopic sinus surgery
- existing nasal septal perforation
- smoker
- diabetes mellitus
- allergy to polylactide-co-glycolide (PLG)
- non-English speaker
Data sourced from ClinicalTrials.gov (NCT01541839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.