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
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
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 design | Interventional prospective single-centre matched-paired randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Postoperative ecchymosis and edema following subperiosteal tunnels in rhinoplasty: a blinded randomised clinical trial |
| Study objectives | To 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) studied | Post-operative ecchymosis and edema in rhinoplasty |
| Intervention | Subjects 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 type | Procedure/Surgery |
| Primary outcome measure | The following are graded on a 0-10 visual analogue scale (VAS) 2 and 7 days after surgery: 1. Ecchymosis 2. Edema |
| Secondary outcome measures | N/A |
| Overall study start date | 01/02/2015 |
| Completion date | 01/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | 1. Age 17 years or older 2. Aesthetic rhinoplasty requiring bilateral osteotomies |
| Key exclusion criteria | 1. 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 enrolment | 01/04/2015 |
| Date of final enrolment | 30/08/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal
H3P 3E5
Canada
Sponsor information
University/education
1001 Decarie Boulevard. Montreal, Quebec, Canada
Montreal
H4A 3J1
Canada
"ROR" |
https://ror.org/01pxwe438 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 30/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish in JAMA Facial Plastics |
| IPD sharing plan | The 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
Editorial Notes
21/11/2023: Protocol (not peer-reviewed uploaded).
04/01/2019: Publication reference added.
