Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541839
• Other study ID #: 00028960
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Device:
• Septal Stapler
This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Post-operative Complications	The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.	3 weeks