Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-10-01
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hybrid Osteoplasty
Participants undergo dorsal hump reduction using a surgical burr (drill) without traditional dorsal osteotomy. The technique allows controlled bone contouring under direct visualization.
Hybrid Osteoplasty
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.
Traditional Osteotomy and Rasping
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.
Traditional Osteotomy and Rasping
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.
Interventions
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Hybrid Osteoplasty
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.
Traditional Osteotomy and Rasping
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dorsal hump with bony or mixed component suitable for either technique.
* No prior nasal surgery or significant nasal trauma affecting dorsum.
* ASA I-III and fit for general anesthesia.
* Willing to provide written informed consent, including standardized photography.
* Able and willing to attend all follow-up visits through 12 months.
Exclusion Criteria
* Active infection, open lesions, or uncontrolled dermatologic conditions at operative field.
* Bleeding diathesis, platelet disorder, INR elevation, or anticoagulant/antiplatelet therapy that cannot be paused.
* Uncontrolled systemic disease (e.g., hypertension, diabetes) or ASA ≥ IV.
* Pregnancy or breastfeeding.
* Chronic isotretinoin use within past 6 months or long-term systemic corticosteroid use.
* Concurrent interventional study that may affect healing or outcomes.
18 Years
ALL
No
Sponsors
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University of Sulaimani
OTHER
Responsible Party
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Assoc. Prof. Dr. Goran Latif Omer
Associate Professor
Principal Investigators
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Goran L Omer, PhD
Role: STUDY_CHAIR
University of Sulaimani
Locations
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Royal Hospital
Sulaymaniyah, KRI, Iraq
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Goodman WS. The rotating burr in rhinoplasty. Arch Otolaryngol. 1981 Jul;107(7):436-8. doi: 10.1001/archotol.1981.00790430038010. No abstract available.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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No. 159 (August 17th, 2025)
Identifier Type: -
Identifier Source: org_study_id
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