Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

University of Alberta

Status: Completed

Conditions: Nasal Obstruction

Treatments: Device: Septal Stapler

Study type: Interventional

Funder types: Other

Identifiers

NCT01541839

00028960

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Septal Stapler

Experimental group

Description:

This group will have closure of their nasal septal flaps via septal stapler.

Treatment:

Device: Septal Stapler

Control (Suture)

No Intervention group

Description:

This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.