Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction
• Intervention / Treatment: Device: Septal Stapler

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Septal Stapler; This group will have closure of their nasal septal flaps via septal stapler.	Device: Septal Stapler; This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.; Other Names: ENTact Septal Stapler (ENTrigue surgical 601-00100)
No Intervention: Control (Suture); 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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Erin D Wright, MDCM, FRCSC, University of Alberta

Publications and helpful links

General Publications

• Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
• Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Nasal septum; Nasal surgical procedures
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 00028960

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No