Clinical trial NCT01541839: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: Nasal septum
Nasal surgical procedures
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Operative Time
timeFrame: 1 day
Secondary outcomes:
measure: Subjective Function
timeFrame: up to 2 months
measure: Post-operative Complications
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Erin D Wright, MDCM, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.