Nasal Obstruction
Conditions
Keywords
Nasal septum, Nasal surgical procedures
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.
Interventions
DEVICESeptal Stapler
This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Function | up to 2 months | 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 |
| Post-operative Complications | 3 weeks | The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician. |
Countries
Canada
Participant flow
Recruitment details
Patients were recruited from the Otolaryngology clinic from February 2012 to May 2012
Participants by arm
| Arm | Count |
|---|---|
| Septal Stapler This group will have closure of their nasal septal flaps via septal stapler. | 8 |
| Control (Suture) This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Control (Suture) | Septal Stapler | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 15 | 38 years STANDARD_DEVIATION 14 |
| Region of Enrollment Canada | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: 1 day
Population: Based on sample size calculation. No patients lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Septal Stapler | Operative Time | 35 seconds | Standard Deviation 23 |
| Control (Suture) | Operative Time | 423 seconds | Standard Deviation 70 |
Secondary
Post-operative Complications
The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.
Time frame: 3 weeks
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Septal Stapler | Post-operative Complications | 1 numberof post-operative complications |
| Control (Suture) | Post-operative Complications | 1 numberof post-operative complications |
Comparison: The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.p-value: <0.0001t-test, 1 sided
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
Time frame: up to 2 months
Population: All participants. None lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Septal Stapler | Subjective Function | 2 units on a scale | Standard Deviation 3 |
| Control (Suture) | Subjective Function | 3 units on a scale | Standard Deviation 2 |