Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Study Overview
=================
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.

Official Title
-----------------
Randomized, Controlled Trial Comparing an Endoscopic Septal Stapler to Suture Closure in Primary Septoplasty

Conditions
-----------------
Nasal Obstruction

Intervention / Treatment
-----------------
* Device: Septal Stapler


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septal Stapler<br>This group will have closure of their nasal septal flaps via septal stapler. | Device: Septal Stapler<br>* This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.<br>* Other names: ENTact Septal Stapler (ENTrigue surgical 601-00100);|
| No Intervention: Control (Suture)<br>This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Function | 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 | up to 2 months | 
| Post-operative Complications | The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal septum, Nasal surgical procedures