Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

• Operative Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  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.
  
  

• Subjective function [ Time Frame: 3 weeks, 2 months ] [ Designated as safety issue: No ]
  The subjective outome of patients undergoing closure with the septal stapler versus suture will be assessed via the Nasal Obstruction Symptom Evaluation questionnaire.
  
  
• Post-operative complications [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  The rate of post-operative complications (synechiae, septal perforation) will be assessed at three week follow-up by a physician.
  
  

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.