Assessing the effects of subperiosteal tunnels in rhinoplasty on post operative bruising and swelling

ISRCTN ISRCTN42741475
DOI https://doi.org/10.1186/ISRCTN42741475
Secondary identifying numbers SPT
Submission date
01/10/2018
Registration date
01/10/2018
Last edited
21/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Bruising and swelling are commonly associated with rhinoplasty (nose reshaping) and are the main factors that limit the return to daily activities. Several methods have been evaluated to minimize this, including the creation of subperiosteal tunnels, which involves raising the superficial vascular layer off the bone, preserving it from trauma during surgery. Our aim is to assess the efficacy of subperiosteal tunnels during rhinoplasty at reducing postoperative bruising and swelling.

Who can participate?
Men and women aged 17 years or older undergoing aesthetic rhinoplasty requiring bilateral osteotomies (cuts to the bony framework of the nose will need to be performed during surgery on both sides)

What does the study involve?
All patients will be undergoing rhinoplasty. They will be randomly allocated to have one side of their nose undergo subperiosteal tunnelling and one side to not (therefore all participants receive subperiosteal tunnelling, but the side that this will be done on is randomly assigned). 2 and 7 days post-surgery, bruising and swelling on each side of the nose will be assessed

What are the possible benefits and risks of participating?
Though the creation of subperiosteal tunnelling is widely performed, there is not much data on whether or not there is a reduction on bruising and swelling. The possible benefits could include less bruising/swelling post operatively on the side of the tunnelling . There are no added risks of surgery for participating subjects/

Where is the study run from?
Montreal Centre for Facial Plastic Surgery (Canada)

When is the study starting and how long is it expected to run for?
February 2015 to February 2017

Who is funding the study?
This study was investigator initiated and funded

Who is the main contact?
Dr Mark Samaha
mark.samaha@mcgill.ca

Contact information

Dr Mark Samaha
Scientific

1001 Decarie Boulevard., Quebec Canada
Department of Otolaryngology – Head & Neck Surgery, Division of Facial Plastic and Reconstructive Surgery
McGill University
Montreal
H4A 3J1
Canada

Study information

Study designInterventional prospective single-centre matched-paired randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePostoperative ecchymosis and edema following subperiosteal tunnels in rhinoplasty: a blinded randomised clinical trial
Study objectivesTo assess the efficacy of subperiosteal tunnels prior to lateral osteotomies during rhinoplasty at reducing postoperative ecchymosis and edema.
Ethics approval(s)McGill University Faculty of Medicine Institutional Review Board, 10/05/2015, IRB Review Number A00-M17-15A
Health condition(s) or problem(s) studiedPost-operative ecchymosis and edema in rhinoplasty
InterventionSubjects were randomly assigned to undergo subperiosteal tunneling on one side of the nose during rhinoplasty. The other side of the nose underwent rhinoplasty without the creation of tunnels. The randomisation process was done using Siri®, the voice activated virtual assistant on an Apple iPhone®, at the time of surgery. Siri® was asked to randomly select a number. If an even number was generated, the patient would undergo creation of subperiosteal tunnels prior to osteotomy in rhinoplasty on the right side. Patients were blinded to the side of the subperiosteal tunnels. Post operatively, 3 blinded evaluators were asked to grade the degree of ecchymosis and edema on each side of the face.
Intervention typeProcedure/Surgery
Primary outcome measureThe following are graded on a 0-10 visual analogue scale (VAS) 2 and 7 days after surgery:
1. Ecchymosis
2. Edema
Secondary outcome measuresN/A
Overall study start date01/02/2015
Completion date01/02/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants34
Key inclusion criteria1. Age 17 years or older
2. Aesthetic rhinoplasty requiring bilateral osteotomies
Key exclusion criteria1. Rhinoplasty without ostetomies
2. Rhinoplasty with unilateral or intermediate osteotomy
3. Not willing to provide informed consent
4. 7 day follow-up not possible due to scheduling conflicts
Date of first enrolment01/04/2015
Date of final enrolment30/08/2015

Locations

Countries of recruitment

  • Canada

Study participating centre

Montreal Centre for Facial Plastic Surgery
1240 Beaumont, Suite 200
Montreal
H3P 3E5
Canada

Sponsor information

McGill University - Department of Otolaryngology Head & Neck Surgery, Division of Facial Plastic and Reconstructive Surgery
University/education

1001 Decarie Boulevard. Montreal, Quebec, Canada
Montreal
H4A 3J1
Canada

ROR logo "ROR" https://ror.org/01pxwe438

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/11/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe intend to publish in JAMA Facial Plastics
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Dr Mark Samaha (mark.samaha@mcgill.ca). Data will be available after publication, from approximately 01/01/2019 until 10/05/2022. The raw data included will be the grading of each participant on ecchymosis and edema by the evaluators on post-operative days 2 and 7. Access will be granted to researchers or institutions that could use our data for further evaluation of this surgical technique, for example for meta-analysis or a systematic review. Access will be granted by the PI (Dr Mark Samaha) upon request. Data will be anonymised by a numerical code and no patient identifiers will be used. Written consent has been obtained from the patients. There are no ethical or legal restrictions.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2019 Yes No
Protocol file 21/11/2023 No No

Additional files

ISRCTN42741475_Protocol.pdf

Editorial Notes

21/11/2023: Protocol (not peer-reviewed uploaded).
04/01/2019: Publication reference added.