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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septal Stapler | Experimental | This group will have closure of their nasal septal flaps via septal stapler. |
|
| Control (Suture) | No Intervention | This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septal Stapler | Device | This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin D Wright, MDCM, FRCSC | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14990910 | Background | 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. | |
| 15054368 | Background | 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. |
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Patients were recruited from the Otolaryngology clinic from February 2012 to May 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Septal Stapler | This group will have closure of their nasal septal flaps via septal stapler. |
| FG001 | Control (Suture) | This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Septal Stapler | This group will have closure of their nasal septal flaps via septal stapler. |
| BG001 | Control (Suture) | This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Based on sample size calculation. No patients lost to follow-up | Posted | Mean | Standard Deviation | seconds | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Septal Stapler | This group will have closure of their nasal septal flaps via septal stapler. |
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Limited by potential bias of surgeon (not blinded to closure method).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Wright | University of Alberta | 780-407-7656 | erin.wright@me.com |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| Post-operative Complications |
The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician. |
| 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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" | All participants. None lost to follow-up | Posted | Mean | Standard Deviation | units on a scale | up to 2 months |
|
|
|
| Secondary | Post-operative Complications | The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician. | All participants | Posted | Number | numberof post-operative complications | 3 weeks |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control (Suture) | This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion. | 0 | 8 | 0 | 8 |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Superiority or Other (legacy) |