Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Not Applicable

Completed

Conditions: Nasal Obstruction

Interventions: Device: Septal Stapler

Registration Number: NCT01541839

Lead Sponsor: University of Alberta

Brief 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.

Detailed Description: Nasal Septoplasty is the third most common surgical procedure performed by otolaryngologists. The surgery is done to relieve nasal obstruction, which is often caused by a bend in the tissues in the middle of the nose. The current technique for completing a septoplasty involves elevating subperichondrial flaps bilaterally and resecting the deviated portion of cartilage and/or bone. The technique to prevent a septal hematoma by removing the potential dead space after cartilage resection has evolved over time. Traditionally, the nose was packed with petroleum gauze, but using sutures to coapt the mucosa back together has become the preferred method of choice.

Placing sutures to reapproximate the mucosa is very effective, but can be challenging, particularly in a narrow nose. The amount of time required varies from 4 to 20 minutes for this part of the surgery, and is potentially associated with its own set of complications. The needle or suture can break, and the lateral nasal wall can be traumatized, leading to formation of scar bands to the septum.

Recently, a septal stapler has been developed that uses bioabsorbable staples. The staples are made of polylactide-co-glycolide (PLG), the same copolymer found in Vicryl sutures. It can provide a more uniform closure, is able to reach the posterior septum and could lead to a significant time savings in the operating room. The stapler has been demonstrated to be safe and effective, and required less than a minute to apply in most studied cases. The amount of time saved in the operating room has not yet been studied.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Septal Stapler	Septal Stapler	This group will have closure of their nasal septal flaps via septal stapler.

Primary Outcome Measures

Name	Time	Method
Operative Time	1 day	The primary outomce of this study is to determine if time is saved in the operating room by using the septal stapler instead of suture.

Secondary Outcome Measures

Name	Time	Method
Post-operative Complications	3 weeks	The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.
Subjective Function	up to 2 months	The subjective outcome of patients undergoing closure with the septal stapler versus suture will be assessed via the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE questionnaire rates a patient's symptoms using a 0-4 scale where 0 is "Not a problem" and 4 is "Severe problem"