Reduce Edema and Ecchymosis After RhinoplastystepcountNCT06202573
Effect of Step Count on Edema After Rhinoplasty
A study testing rhinoplasty in people with Reduce Edema and Ecchymosis After Rhinoplasty, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Rhinoplasty surgery is being performed in increasing numbers in our country and around the world. After rhinoplasty surgery, patients experience swelling and bruising (ecchymosis) in their eyes. Many methods have been used to reduce this edema and bruising. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Reduce Edema and Ecchymosis After Rhinoplasty
- What is being tested?
- rhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of Dr. Salih Aydın
Who cannot join
- revision septorhinoplasty surgery, those with a chronic diagnosed disease such as concomitant diabetes, surgeries performed with conventional osteotomy, surgeries without osteotomy. Measurements made with smart watches other than Xiaomi band 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Number of Steps on Edema and Ecchymosis Due to Rhinoplasty Surgery
Rhinoplasty surgery is being performed in increasing numbers in our country and around the world. After rhinoplasty surgery, patients experience swelling and bruising (ecchymosis) in their eyes. Many methods have been used to reduce this edema and bruising. Some of these methods are surgical techniques, medications, and supportive treatments used during and after surgery. (cortisol, vitamins, ice applications, etc.) When the literature is examined, there is currently no consensus on methods that reduce swelling and bruising. Again, in meta-analysis studies, there is no prominent or definitive method for reducing bruising and swelling. In our clinical observations, it has been observed that edema and bruising are significantly less common in tourists coming to our country from abroad. The idea that the reason for this may be that tourists walk a lot when they come to Istanbul, they want to travel a lot and see new places, has emerged as a hypothesis in our minds. The relationship between the number of steps taken during the day and postoperative edema-ecchymosis has not been examined before in the literature. In this respect, we think that our study will contribute to the literature.
Read the detailed description
Edema and ecchymosis occurring in the eyes and face after rhinoplasty surgery greatly reduce the quality of life of patients. Many studies have been conducted in the literature to reduce this edema and ecchymosis. However, there is currently no successful method in the literature. Our aim in our study is to mobilize patients early after surgery and to investigate the effect of the number of steps they take after surgery on edema and attachment. For this purpose, 5 cohort groups will be created from patients who underwent rhinoplasty surgery by the same doctor. Patients will be randomly assigned to groups. The study was planned as a prospective, non-randomized, controlled study with parallel groups. Consecutive patients undergoing primary open septorhinoplasty were allocated to one of five predefined postoperative management groups in a fixed sequential rotation according to the order of surgery. Allocation was sequential and non-random. Outcome assessment was performed by an independent assessor blinded to group allocation.
Group A: patients who have a step counter and whom we do not motivate to walk Group B: control group patients with and without step counters Group C: patients who have a step counter and whom we motivate to take at least 5000 steps Group D: patients with step counters, whom we motivated to take at least 10000 steps Group E: patients who have a step counter, who do not motivate us to walk, and who will apply ice only on the 1st day after surgery
Criteria for inclusion in the study: Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of 1 researcher doctors (Dr. Salih Aydın).
Criteria for inclusion in the study: revision septorhinoplasty surgery, patients with a chronic diagnosed disease such as diabetes, surgeries performed with conventional osteotomy, and surgeries without osteotomy. Measurements made with smartwatches other than the Xiaomi Band 5
The information of the patients participating in the study will be recorded on the forms. In this form: age, gender, accompanying diseases, smoking, drug use, occupation, doctor performing the surgery, duration of surgery (between intubation and extubation), end time of the surgery, the time he started walking on the first day, the number of steps taken on the first day and for 9 days. The daily step count (new day recordings will start at midnight) will be recorded. Patients will be asked to take facial photographs in the morning and evening. These photographs will be evaluated and noted using the edema-ecchymosis scale by a blind investigator. "Xiaomi Mi Band 5 smart bracelet" will be used to determine the number of steps taken. These wristbands will be given to the patients by the doctor performing the surgery and will be taken back at the end of the study. In light of the data obtained, the effect of early postoperative mobilization and the number of steps on edema and ecchymosis will be revealed.
- Being tested
- rhinoplasty
- Keywords
- Rhinoplasty, edeme, ecchymosis, step count
- Medical subject headings
- Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhinoplastyProcedure or surgery
patients who have a step counter and we do not motivate them to walk
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | received the tracker without any walking target. Receives: Procedure: rhinoplasty |
| Group E | Active comparator | received the tracker without a walking target but underwent an extended cold application protocol on postoperative Day 1 Receives: Procedure: rhinoplasty |
| group C | Active comparator | Groups C wad given daily targets of at least 5,000 steps reinforced by daily reminders. Receives: Procedure: rhinoplasty |
| group D | Active comparator | Groups D was given daily targets of at least 10,000 steps respectively, reinforced by daily reminders. Receives: Procedure: rhinoplasty |
| group B | Active comparator | Group B received standard postoperative care without a tracker or walking advice and served as the pedometer-free control group Receives: Procedure: rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Step Count on Edema After Rhinoplasty
prospective study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start5 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduce Edema and Ecchymosis After RhinoplastyStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized, controlled study with parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Aydın, Istinye University
- Investigators
- Salih Aydin, Prof.Dr., Principal investigator, İstinye Medical Faculty, Otorhinolaryngology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202573
- Sponsor's protocol ID
- rhino-step
- Acronym
- stepcount
- Status last verified
- Jul 2026
- First submitted
- 1 Jan 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Number of Steps on Edema and Ecchymosis Due to Rhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT06202573
- Acronym / sponsor ID
- stepcount / rhino-step
- Keywords
- Rhinoplasty, edeme, ecchymosis, step count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rhinoplasty surgery is being performed in increasing numbers in our country and around the world. After rhinoplasty surgery, patients experience swelling and bruising (ecchymosis) in their eyes. Many methods have been used to reduce this edema and bruising. Some of these methods are surgical techniques, medications, and supportive treatments used during and after surgery. (cortisol, vitamins, ice applications, etc.) When the literature is examined, there is currently no consensus on methods that reduce swelling and bruising. Again, in meta-analysis studies, there is no prominent or definitive method for reducing bruising and swelling. In our clinical observations, it has been observed that edema and bruising are significantly less common in tourists coming to our country from abroad. The idea that the reason for this may be that tourists walk a lot when they come to Istanbul, they want to travel a lot and see new places, has emerged as a hypothesis in our minds. The relationship between the number of steps taken during the day and postoperative edema-ecchymosis has not been examined before in the literature. In this respect, we think that our study will contribute to the literature.
Detailed description
Edema and ecchymosis occurring in the eyes and face after rhinoplasty surgery greatly reduce the quality of life of patients. Many studies have been conducted in the literature to reduce this edema and ecchymosis. However, there is currently no successful method in the literature. Our aim in our study is to mobilize patients early after surgery and to investigate the effect of the number of steps they take after surgery on edema and attachment. For this purpose, 5 cohort groups will be created from patients who underwent rhinoplasty surgery by the same doctor. Patients will be randomly assigned to groups. The study was planned as a prospective, non-randomized, controlled study with parallel groups. Consecutive patients undergoing primary open septorhinoplasty were allocated to one of five predefined postoperative management groups in a fixed sequential rotation according to the order of surgery. Allocation was sequential and non-random. Outcome assessment was performed by an independent assessor blinded to group allocation.
Group A: patients who have a step counter and whom we do not motivate to walk Group B: control group patients with and without step counters Group C: patients who have a step counter and whom we motivate to take at least 5000 steps Group D: patients with step counters, whom we motivated to take at least 10000 steps Group E: patients who have a step counter, who do not motivate us to walk, and who will apply ice only on the 1st day after surgery
Criteria for inclusion in the study: Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of 1 researcher doctors (Dr. Salih Aydın).
Criteria for inclusion in the study: revision septorhinoplasty surgery, patients with a chronic diagnosed disease such as diabetes, surgeries performed with conventional osteotomy, and surgeries without osteotomy. Measurements made with smartwatches other than the Xiaomi Band 5
The information of the patients participating in the study will be recorded on the forms. In this form: age, gender, accompanying diseases, smoking, drug use, occupation, doctor performing the surgery, duration of surgery (between intubation and extubation), end time of the surgery, the time he started walking on the first day, the number of steps taken on the first day and for 9 days. The daily step count (new day recordings will start at midnight) will be recorded. Patients will be asked to take facial photographs in the morning and evening. These photographs will be evaluated and noted using the edema-ecchymosis scale by a blind investigator. "Xiaomi Mi Band 5 smart bracelet" will be used to determine the number of steps taken. These wristbands will be given to the patients by the doctor performing the surgery and will be taken back at the end of the study. In light of the data obtained, the effect of early postoperative mobilization and the number of steps on edema and ecchymosis will be revealed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- non-randomized, controlled study with parallel groups.
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: rhinoplastyreceived the tracker without any walking target. |
| Group E | Active comparator | Procedure: rhinoplastyreceived the tracker without a walking target but underwent an extended cold application protocol on postoperative Day 1 |
| group C | Active comparator | Procedure: rhinoplastyGroups C wad given daily targets of at least 5,000 steps reinforced by daily reminders. |
| group D | Active comparator | Procedure: rhinoplastyGroups D was given daily targets of at least 10,000 steps respectively, reinforced by daily reminders. |
| group B | Active comparator | Procedure: rhinoplastyGroup B received standard postoperative care without a tracker or walking advice and served as the pedometer-free control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of Dr. Salih Aydın
Key exclusion criteria (1 listed)
- revision septorhinoplasty surgery, those with a chronic diagnosed disease such as concomitant diabetes, surgeries performed with conventional osteotomy, surgeries without osteotomy. Measurements made with smart watches other than Xiaomi band 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhinoplastypatients who have a step counter and we do not motivate them to walk | Procedure or surgery | Group E, group A, group B, group C, group D |
Primary outcome
Effect of Step Count on Edema After Rhinoplasty
Time frame: 6 months
prospective study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salih Aydin, Prof.Dr. principal investigator
İstinye Medical Faculty, Otorhinolaryngology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhinoplasty in people with Reduce Edema and Ecchymosis After Rhinoplasty, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Step Count on Edema After Rhinoplasty (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.