Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01541839
Recruitment Status : Unknown
Verified February 2012 by University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : March 1, 2012
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Device: Septal Stapler Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Trial Comparing an Endoscopic Septal Stapler to Suture Closure in Primary Septoplasty
Study Start Date : February 2012
Estimated Primary Completion Date : September 2012

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 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.

Primary Outcome Measures :
  1. Operative Time [ Time Frame: 1 day ]
    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 :
  1. Subjective function [ Time Frame: 3 weeks, 2 months ]
    The subjective outome of patients undergoing closure with the septal stapler versus suture will be assessed via the Nasal Obstruction Symptom Evaluation questionnaire.

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01541839

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

Responsible Party: University of Alberta Identifier: NCT01541839     History of Changes
Other Study ID Numbers: 00028960
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

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