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This study is designed to compare two common techniques for reducing the nasal hump during rhinoplasty: the traditional method using osteotomes and rasps, and a newer technique called hybrid osteoplasty that uses a surgical drill. Both approaches aim to improve the appearance and function of the nose. The trial will measure pain, swelling, bruising, and the smoothness of the nasal bridge, as well as patient satisfaction and breathing outcomes. Participants will be followed for one year to assess both early healing and long-term results.
This prospective randomized controlled trial will evaluate the aesthetic and functional outcomes of hybrid osteoplasty using a surgical burr compared with traditional osteotomy and rasping in primary open rhinoplasty patients presenting with dorsal humps. The study population consists of adults without prior nasal surgery, trauma, or congenital deformities. Patients are randomized into two groups: Group A (hybrid osteoplasty) and Group B (traditional osteotomy plus rasping).
The primary objective is to assess differences in postoperative pain, edema, ecchymosis, dorsal smoothness, contour regularity, and patient satisfaction. Secondary outcomes include functional improvement measured by the Nasal Obstruction Symptom Evaluation (NOSE) score, aesthetic satisfaction assessed by the Rhinoplasty Outcome Evaluation (ROE), and the rate of revision surgery within 12 months.
Follow-up assessments are scheduled on postoperative Days 1, 2, and 7, and at 1, 3, 6, and 12 months. Standardized photographic documentation will support aesthetic evaluation, while clinical scoring systems will provide objective and subjective outcome data. The trial is powered to identify whether hybrid osteoplasty offers advantages in contour refinement and reduced soft tissue trauma compared with conventional osteotomy-based approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Osteoplasty | Experimental | Participants undergo dorsal hump reduction using a surgical burr (drill) without traditional dorsal osteotomy. The technique allows controlled bone contouring under direct visualization. |
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| Traditional Osteotomy and Rasping | Active Comparator | Participants undergo dorsal hump reduction using the conventional method of osteotomy combined with rasping. This is the established standard approach for contouring the nasal dorsum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Osteoplasty | Procedure | Open rhinoplasty with dorsal hump reduction performed using a powered surgical burr under irrigation and direct visualization. Bone is contoured gradually to achieve a smooth dorsum while preserving the keystone area. No dorsal osteotomy is performed in this arm. Cartilaginous work and adjunctive steps (e.g., septoplasty or tip refinement) are performed as clinically indicated but are not part of the intervention being tested. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months | ROE (Rhinoplasty Outcome Evaluation) questionnaire scored 0-100 (higher = greater satisfaction). Score calculated per instrument guidance from the 6 items, converted to 0-100. Change is 12-month minus preoperative score. | Baseline (preoperative) and 12 months post-operation. |
| Mean Dorsal Contour Irregularity Score on Blinded Photographic Assessment at 12 Months | Standardized 7-view photographs rated by three blinded surgeons using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe irregularity). Primary analysis compares group means; inter-rater agreement assessed. | 12 months post-operation. |
| Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7 | 3 Clinicians-rated 4-point edema scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). | Post-op Day 1 and Day 7. |
| Mean Periorbital Ecchymosis Score on 4-Point Clinician Scale at Day 1 and Day 7 | 3 Clinician-rated 4-point ecchymosis scale (0-3). | Post-op Day 1 and Day 7. |
| Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months | Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors. | 12 months post-operation |
| Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months | Symmetry rated by 3 blinded assessors on 3-point scale (symmetric / mildly asymmetric / asymmetric) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months | Smooth vs Irregular, reported by 3 assessors | 12 months post-operation |
| Mean Change in Nasal Obstruction Symptom Evaluation (NOSE) Score from Baseline to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Goran L Omer, PhD | Contact | +9647721524848 | goran.omer@univsul.edu.iq | |
| Sahand S. Ali, MD | Contact | +9647729968844 | sahand.soran@auis.edu.krd |
| Name | Affiliation | Role |
|---|---|---|
| Goran L Omer, PhD | University of Sulaimani | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Hospital | Sulaymaniyah | KRI | 46001 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36971222 | Background | Azizli E, Bayar Muluk N, Dundar R, Cingi C. A new preservation technique for dehumping the dorsum. Eur Rev Med Pharmacol Sci. 2023 Mar;27(2 Suppl):57-62. doi: 10.26355/eurrev_202303_31703. | |
| 26862972 | Background | Ferreira MG, Monteiro D, Reis C, Almeida e Sousa C. Spare Roof Technique: A Middle Third New Technique. Facial Plast Surg. 2016 Feb;32(1):111-6. doi: 10.1055/s-0035-1570503. Epub 2016 Feb 10. |
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De-identified individual participant data (IPD) underlying the published results will be shared, including baseline demographic information, surgical technique allocation, intraoperative variables, and postoperative outcome measures (pain scores, edema, ecchymosis, ROE scores, NOSE scores, blinded photographic assessments, and revision status). Data will be available in de-identified form upon reasonable request to the principal investigator after publication of the primary results. Supporting documents, including the study protocol and statistical analysis plan, will also be made available.
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IPD and supporting information will be available beginning after publication of the primary study results and will remain available for a minimum of 5 years thereafter.
De-identified IPD and supporting documents will be made available to qualified researchers affiliated with academic institutions or recognized research organizations. Requests must include a methodologically sound proposal and will be reviewed by the principal investigator. Approved requestors will be required to sign a data use agreement ensuring compliance with ethical and confidentiality standards. Data will be provided in de-identified format via secure transfer.
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| Traditional Osteotomy and Rasping | Procedure | Open rhinoplasty using the conventional technique for dorsal hump reduction. The bony hump is resected with a straight osteotome, followed by manual rasping to refine the nasal dorsum, with preservation of the keystone area. Powered burrs are not used for primary dorsal contouring in this arm. Cartilaginous work and adjunctive procedures may be performed as clinically indicated but are not part of the tested intervention. |
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| 12 months post-operation |
| Number of Participants Requiring Unplanned Revision Surgery within 12 Months | Any unplanned surgical revision related to the nasal dorsum | Within 12 months post-operation |
NOSE questionnaire scored 0-100 (higher = worse obstruction). Change is 12-month minus preoperative score; negative values indicate improvement. |
| Baseline (preoperative) and 12 months post-operation. |
| Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7 | Pain measured on a 0-10 visual analogue scale (higher = more pain) | Post-op Day 0 and Day 7 |
| Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months | Presence of palpable or visible dorsal callus on clinical exam (Yes/No). 3 assessors. | 3 and 6 months post-operation |
| 39258281 | Background | Aldosari BF, Alhajress RI, Bogari AO. Hump Rasping Using Powered Instruments: A Retrospective Review. Plast Reconstr Surg Glob Open. 2024 Sep 10;12(9):e6153. doi: 10.1097/GOX.0000000000006153. eCollection 2024 Sep. |
| 23119498 | Background | Lal GN, Ghosh P. Use of drill in rhinoplasty (a case report). Indian J Otolaryngol Head Neck Surg. 1999 Jan;51(1):90-2. doi: 10.1007/BF02996859. |
| 7247809 | Background | Goodman WS. The rotating burr in rhinoplasty. Arch Otolaryngol. 1981 Jul;107(7):436-8. doi: 10.1001/archotol.1981.00790430038010. No abstract available. |
| 32195860 | Background | Avashia YJ, Marshall AP, Allori AC, Rohrich RJ, Marcus JR. Decision-Making in Middle Vault Reconstruction following Dorsal Hump Reduction in Primary Rhinoplasty. Plast Reconstr Surg. 2020 Jun;145(6):1389-1401. doi: 10.1097/PRS.0000000000006850. |
| 28388791 | Background | Barrett DM, Casanueva F, Wang T. Understanding Approaches to the Dorsal Hump. Facial Plast Surg. 2017 Apr;33(2):125-132. doi: 10.1055/s-0037-1598033. Epub 2017 Apr 7. |
| 33220838 | Background | Fuller JC, Hilger PA. Modified Skoog Method for Hump Reduction. Facial Plast Surg Clin North Am. 2021 Feb;29(1):131-139. doi: 10.1016/j.fsc.2020.09.008. |
| 28241228 | Background | Sowder JC, Thomas AJ, Gonzalez CD, Limaye NS, Ward PD. Use of Spreader Flaps Without Dorsal Hump Reduction and the Effect on Nasal Function. JAMA Facial Plast Surg. 2017 Jul 1;19(4):287-292. doi: 10.1001/jamafacial.2016.2057. |
| 26616694 | Background | Azizzadeh B, Reilly M. Dorsal Hump Reduction and Osteotomies. Clin Plast Surg. 2016 Jan;43(1):47-58. doi: 10.1016/j.cps.2015.09.022. Epub 2015 Oct 23. |
| 24263393 | Background | Roostaeian J, Unger JG, Lee MR, Geissler P, Rohrich RJ. Reconstitution of the nasal dorsum following component dorsal reduction in primary rhinoplasty. Plast Reconstr Surg. 2014 Mar;133(3):509-518. doi: 10.1097/01.prs.0000438453.29980.36. |
| 15457053 | Background | Rohrich RJ, Muzaffar AR, Janis JE. Component dorsal hump reduction: the importance of maintaining dorsal aesthetic lines in rhinoplasty. Plast Reconstr Surg. 2004 Oct;114(5):1298-308; discussion 1309-12. doi: 10.1097/01.prs.0000135861.45986.cf. |