Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
Primary Purpose
Rhinoplasty, Ecchymosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct compression
Sponsored by
About this trial
This is an interventional prevention trial for Rhinoplasty
Eligibility Criteria
Inclusion Criteria:
- All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy
Exclusion Criteria:
- Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Compression
No compression
Arm Description
Each patient will be randomized to receive compression of their nose on either the left or right for 5 continuous minutes after performing a lateral rhinotomy.
Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.
Outcomes
Primary Outcome Measures
Periorbital edema and ecchymosis
The primary outcome of this study is periorbital edema and ecchymosis. Post-operative photographs will be graded by two staff Otolaryngologists and two senior Otolaryngology residents. Each evaluator will be presented a photograph of a patient and be asked to grade the degree of periorbital edema and ecchymosis for the left and right side. Previously published grading scales will be used. The evaluators will be blinded to the allocated side of nasal pressure and to the post-operative day of the photographs.
Secondary Outcome Measures
Full Information
NCT ID
NCT02319954
First Posted
December 14, 2014
Last Updated
November 2, 2018
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02319954
Brief Title
Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
Official Title
Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. This is due to injury to the angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. Most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. Numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. These include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. Both groups received a pre-operative dose of intravenous steroids. The study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. As such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoplasty, Ecchymosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression
Arm Type
Active Comparator
Arm Description
Each patient will be randomized to receive compression of their nose on either the left or right for 5 continuous minutes after performing a lateral rhinotomy.
Arm Title
No compression
Arm Type
No Intervention
Arm Description
Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.
Intervention Type
Procedure
Intervention Name(s)
Direct compression
Intervention Description
Direct compression by the surgeon with their hands on the nasal sidewall
Primary Outcome Measure Information:
Title
Periorbital edema and ecchymosis
Description
The primary outcome of this study is periorbital edema and ecchymosis. Post-operative photographs will be graded by two staff Otolaryngologists and two senior Otolaryngology residents. Each evaluator will be presented a photograph of a patient and be asked to grade the degree of periorbital edema and ecchymosis for the left and right side. Previously published grading scales will be used. The evaluators will be blinded to the allocated side of nasal pressure and to the post-operative day of the photographs.
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy
Exclusion Criteria:
Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21493314
Citation
Taskin U, Yigit O, Bilici S, Kuvat SV, Sisman AS, Celebi S. Efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. Otolaryngol Head Neck Surg. 2011 May;144(5):698-702. doi: 10.1177/0194599811400377.
Results Reference
background
PubMed Identifier
22795164
Citation
Tuncel U, Turan A, Bayraktar MA, Erkorkmaz U, Kostakoglu N. Efficacy of dexamethasone with controlled hypotension on intraoperative bleeding, postoperative oedema and ecchymosis in rhinoplasty. J Craniomaxillofac Surg. 2013 Mar;41(2):124-8. doi: 10.1016/j.jcms.2012.06.003. Epub 2012 Jul 12.
Results Reference
background
PubMed Identifier
17572575
Citation
Totonchi A, Guyuron B. A randomized, controlled comparison between arnica and steroids in the management of postrhinoplasty ecchymosis and edema. Plast Reconstr Surg. 2007 Jul;120(1):271-274. doi: 10.1097/01.prs.0000264397.80585.bd.
Results Reference
background
PubMed Identifier
21813878
Citation
Hatef DA, Ellsworth WA, Allen JN, Bullocks JM, Hollier LH Jr, Stal S. Perioperative steroids for minimizing edema and ecchymosis after rhinoplasty: a meta-analysis. Aesthet Surg J. 2011 Aug;31(6):648-57. doi: 10.1177/1090820X11416110.
Results Reference
background
PubMed Identifier
21458231
Citation
Gun R, Yorgancilar E, Yildirim M, Bakir S, Topcu I, Akkus Z. Effects of lidocaine and adrenaline combination on postoperative edema and ecchymosis in rhinoplasty. Int J Oral Maxillofac Surg. 2011 Jul;40(7):722-9. doi: 10.1016/j.ijom.2011.02.022. Epub 2011 Apr 1.
Results Reference
background
PubMed Identifier
24531244
Citation
Kosucu M, Omur S, Besir A, Uraloglu M, Topbas M, Livaoglu M. Effects of perioperative remifentanil with controlled hypotension on intraoperative bleeding and postoperative edema and ecchymosis in open rhinoplasty. J Craniofac Surg. 2014 Mar;25(2):471-5. doi: 10.1097/SCS.0000000000000603.
Results Reference
background
PubMed Identifier
18838319
Citation
Al-Arfaj A, Al-Qattan M, Al-Harethy S, Al-Zahrani K. Effect of periosteum elevation on periorbital ecchymosis in rhinoplasty. J Plast Reconstr Aesthet Surg. 2009 Nov;62(11):e538-9. doi: 10.1016/j.bjps.2008.05.047. Epub 2008 Oct 5. No abstract available.
Results Reference
background
PubMed Identifier
16094573
Citation
Kara CO, Kara IG, Topuz B. Does creating a subperiosteal tunnel influence the periorbital edema and ecchymosis in rhinoplasty? J Oral Maxillofac Surg. 2005 Aug;63(8):1088-90. doi: 10.1016/j.joms.2005.04.008.
Results Reference
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Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
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