Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01541839
First received: February 24, 2012
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Nasal Obstruction
Device: Septal Stapler

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial Comparing an Endoscopic Septal Stapler to Suture Closure in Primary Septoplasty

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks, 2 months ] [ Designated as safety issue: No ]
    The subjective outome of patients undergoing closure with the septal stapler versus suture will be assessed via the Nasal Obstruction Symptom Evaluation questionnaire.

  • Post-operative complications [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    The rate of post-operative complications (synechiae, septal perforation) will be assessed at three week follow-up by a physician.


Estimated Enrollment: 16
Study Start Date: February 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541839

Locations
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Erin D Wright, MDCM, FRCSC University of Alberta
  More Information

Publications:
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01541839     History of Changes
Other Study ID Numbers: 00028960
Study First Received: February 24, 2012
Last Updated: February 29, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Nasal septum
Nasal surgical procedures

Additional relevant MeSH terms:
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014