Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

NCT ID: NCT01541839

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-03-31

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.

Conditions

Nasal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Septal Stapler

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

Group Type: EXPERIMENTAL

Septal Stapler

Intervention Type: DEVICE

This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.

Control (Suture)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Septal Stapler

This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.

Intervention Type: DEVICE

Other Intervention Names

ENTact Septal Stapler (ENTrigue surgical 601-00100)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin D Wright, MDCM, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 14990910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15054368 (View on PubMed)

Other Identifiers

00028960

Identifier Type: -

Identifier Source: org_study_id