Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Septal Stapler
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction focused on measuring Nasal septum, Nasal surgical procedures
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
Sites / Locations
- Royal Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Septal Stapler
Control (Suture)
Arm Description
This group will have closure of their nasal septal flaps via septal stapler.
This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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"
Post-operative Complications
The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.
Full Information
NCT ID
NCT01541839
First Posted
February 24, 2012
Last Updated
January 9, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01541839
Brief Title
Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty
Official Title
Randomized, Controlled Trial Comparing an Endoscopic Septal Stapler to Suture Closure in Primary Septoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
Keywords
Nasal septum, Nasal surgical procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Septal Stapler
Arm Type
Experimental
Arm Description
This group will have closure of their nasal septal flaps via septal stapler.
Arm Title
Control (Suture)
Arm Type
No Intervention
Arm Description
This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Intervention Type
Device
Intervention Name(s)
Septal Stapler
Other Intervention Name(s)
ENTact Septal Stapler (ENTrigue surgical 601-00100)
Intervention Description
This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.
Primary Outcome Measure Information:
Title
Operative Time
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Subjective Function
Description
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"
Time Frame
up to 2 months
Title
Post-operative Complications
Description
The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin D Wright, MDCM, FRCSC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
14990910
Citation
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.
Results Reference
background
PubMed Identifier
15054368
Citation
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.
Results Reference
background
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Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty
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