N/A N=16 Randomized Single-blind Treatment

Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Nasal Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT01541839 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Operative Time — 35; 423 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Septal Stapler (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: Feb 2013

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

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.

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

View full record on ClinicalTrials.gov →

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.