RhinoplastyNCT06649370
Effect of Systemic Inflammatory Index and Systemic Immune Inflammation Index on Ecchymosis, Bleeding and Edema
An observational study of Rhinoplasty, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Rhinoplasty is a cosmetic surgical procedure that is widely applied today and is characterized by edema in the postoperative period. In particular, edema can cause prolonged recovery and deterioration in the patient's social life. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- Hypotensive Drugs and/or Vasoactive Drugs
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jan 2026
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This prospective, randomized, controlled observational study will be conducted on patients undergoing open rhinoplasty with osteotomy. Rhinoplasty patients aged 18-45 years who will undergo general anesthesia and have an American Society of Anesthesiologists (ASA) score of 1 and 2 will be included in the study. The sample size was calculated with a type 1 error value of 0.05, a power of 0.80 and r = 0.30 (low-level correlation) between the systemic inflammatory index and edema score, and 85 patients were considered sufficient for the study. Considering the losses that may occur during follow-up, it was planned to conduct the study with 94 patients with a 10% increase.
Who may be able to join
- Patients who are planning to undergo rhinoplasty and are between the ages of 18-45 are willing to participate in the study.
Who cannot join
- Heart failure
- Severe respiratory failure
- Renal failure
- Vascular diseases
- Steroid use
- Coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Center, 600100
About this study
Official title: Effect of Systemic Inflammatory Index and Systemic Immune Inflammation Index on Ecchymosis, Bleeding and Edema in Rhinoplasty.
Rhinoplasty is a cosmetic surgical procedure that is widely applied today and is characterized by edema in the postoperative period. In particular, edema can cause prolonged recovery and deterioration in the patient's social life. Various studies have been conducted using certain drugs or different surgical techniques to reduce edema and ecchymosis in rhinoplasty.
In rhinoplasty, edema occurs after the absorption of interstitial fluid in the nose is disrupted as a result of trauma to the bone and soft tissue. Ecchymosis occurs when blood passes from damaged vessels due to surgery to the loose and thin soft tissue around the eye. Ecchymosis is often seen on the eyelids after open rhinoplasty. Ecchymosis usually moves in the direction of gravity and increases in the first two days after surgery.
Systemic inflammatory response index and systemic immune inflammation index can be easily obtained with a simple hemogram test. These indexes have been suggested to be a useful parameter in many diseases associated with inflammation, but research is still ongoing. Inflammation values and the resulting response have an important effect on wound formation and healing. However, increased inflammation can also increase edema and ecchymosis in the postoperative period. In this study, the researchers aimed to investigate the relationship between preoperative inflammation values and postoperative edema and ecchymosis in open rhinoplasties.
Read the detailed description
Although rhinoplasty is one of the most commonly performed facial surgical procedures, intraoperative bleeding, postoperative ecchymosis and edema negatively affect patient satisfaction. No matter how gently and carefully the surgeon performs the procedure in rhinoplasty, trauma, inflammation and as a result edema and ecchymosis develop in the tissues. Edema and ecchymosis can cause temporary vision loss, permanent pigmentation and scar tissue. Studies have been conducted using different drugs such as steroids, adrenaline and lidocaine to reduce edema and ecchymosis in rhinoplasty surgery and different osteotomy techniques in rhinoplasty. In patients undergoing rhinoplasty, inflammation of the nasal mucosa at the osteotomy site is an important cause of periorbital edema and ecchymosis. The systemic inflammatory response index is an easily accessible and calculable biomarker that provides important information about inflammatory conditions and inflammatory diseases. This simple index shows the balance between regulatory and protective lymphocytes, neutrophils and active inflammatory components. In addition to inflammation, this index also provides information about vascular involvement and damage in some diseases. Leukocytes further increase inflammation in damaged vessels, increasing endothelial damage and the risk of thrombus. Rhinoplasty is a commonly performed surgical procedure, and postoperatively, even during the surgical procedure, ecchymosis and edema can be seen around the eyes and face. This affects the patient's recovery, discharge, and return to social life. Many studies have been conducted to reduce postoperative edema and ecchymosis in rhinoplasty. However, it is very important to be able to predict the severity of edema and ecchymosis in advance. There are not enough studies on this subject, and the results are contradictory. Therefore, the aim of this study was to investigate whether there is a relationship between the systemic inflammatory response index and systemic immune inflammation index, which are measured before surgery in rhinoplasty, and postoperative ecchymosis and edema.
- Conditions
- Rhinoplasty
- Being tested
- Hypotensive Drugs and/or Vasoactive Drugs
- Keywords
- Ecchymosis, Edema, Inflammation, Platelet Count
- Medical subject headings
- Ecchymosis, Edema, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotensive Drugs and/or Vasoactive DrugsDrug
If the patients' mean arterial pressure falls below 60 mmHg or 20% below the preoperative value, ephedrine will be administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative edema and ecchymosis
Each patient will be photographed with a digital camera on postoperative days 1, 2, and 7. Eyelid edema and periorbital soft tissue ecchymosis will be assessed using a separate grading scale (range 0-4). The assessment will be performed by an independent observer for each patient on the indicated days.
Measured: Each patient will be evaluated on postoperative days 1, 2 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649370
- Sponsor's protocol ID
- 24-KAEK-185
- Status last verified
- Aug 2025
- First submitted
- 17 Oct 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Inflammatory Index and Systemic Immune Inflammation Index on Ecchymosis, Bleeding and Edema in Rhinoplasty.
- ClinicalTrials.gov ID
- NCT06649370
- Acronym / sponsor ID
- 24-KAEK-185
- Conditions
- Rhinoplasty
- Keywords
- Ecchymosis, Edema, Inflammation, Platelet Count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 18 Oct 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 is a cosmetic surgical procedure that is widely applied today and is characterized by edema in the postoperative period. In particular, edema can cause prolonged recovery and deterioration in the patient's social life. Various studies have been conducted using certain drugs or different surgical techniques to reduce edema and ecchymosis in rhinoplasty.
In rhinoplasty, edema occurs after the absorption of interstitial fluid in the nose is disrupted as a result of trauma to the bone and soft tissue. Ecchymosis occurs when blood passes from damaged vessels due to surgery to the loose and thin soft tissue around the eye. Ecchymosis is often seen on the eyelids after open rhinoplasty. Ecchymosis usually moves in the direction of gravity and increases in the first two days after surgery.
Systemic inflammatory response index and systemic immune inflammation index can be easily obtained with a simple hemogram test. These indexes have been suggested to be a useful parameter in many diseases associated with inflammation, but research is still ongoing. Inflammation values and the resulting response have an important effect on wound formation and healing. However, increased inflammation can also increase edema and ecchymosis in the postoperative period. In this study, the researchers aimed to investigate the relationship between preoperative inflammation values and postoperative edema and ecchymosis in open rhinoplasties.
Detailed description
Although rhinoplasty is one of the most commonly performed facial surgical procedures, intraoperative bleeding, postoperative ecchymosis and edema negatively affect patient satisfaction. No matter how gently and carefully the surgeon performs the procedure in rhinoplasty, trauma, inflammation and as a result edema and ecchymosis develop in the tissues. Edema and ecchymosis can cause temporary vision loss, permanent pigmentation and scar tissue. Studies have been conducted using different drugs such as steroids, adrenaline and lidocaine to reduce edema and ecchymosis in rhinoplasty surgery and different osteotomy techniques in rhinoplasty. In patients undergoing rhinoplasty, inflammation of the nasal mucosa at the osteotomy site is an important cause of periorbital edema and ecchymosis. The systemic inflammatory response index is an easily accessible and calculable biomarker that provides important information about inflammatory conditions and inflammatory diseases. This simple index shows the balance between regulatory and protective lymphocytes, neutrophils and active inflammatory components. In addition to inflammation, this index also provides information about vascular involvement and damage in some diseases. Leukocytes further increase inflammation in damaged vessels, increasing endothelial damage and the risk of thrombus. Rhinoplasty is a commonly performed surgical procedure, and postoperatively, even during the surgical procedure, ecchymosis and edema can be seen around the eyes and face. This affects the patient's recovery, discharge, and return to social life. Many studies have been conducted to reduce postoperative edema and ecchymosis in rhinoplasty. However, it is very important to be able to predict the severity of edema and ecchymosis in advance. There are not enough studies on this subject, and the results are contradictory. Therefore, the aim of this study was to investigate whether there is a relationship between the systemic inflammatory response index and systemic immune inflammation index, which are measured before surgery in rhinoplasty, and postoperative ecchymosis and edema.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective, randomized, controlled observational study will be conducted on patients undergoing open rhinoplasty with osteotomy. Rhinoplasty patients aged 18-45 years who will undergo general anesthesia and have an American Society of Anesthesiologists (ASA) score of 1 and 2 will be included in the study. The sample size was calculated with a type 1 error value of 0.05, a power of 0.80 and r = 0.30 (low-level correlation) between the systemic inflammatory index and edema score, and 85 patients were considered sufficient for the study. Considering the losses that may occur during follow-up, it was planned to conduct the study with 94 patients with a 10% increase.
Key inclusion criteria (1 listed)
- Patients who are planning to undergo rhinoplasty and are between the ages of 18-45 are willing to participate in the study.
Key exclusion criteria (6 listed)
- Heart failure
- Severe respiratory failure
- Renal failure
- Vascular diseases
- Steroid use
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 |
|---|---|---|
| Hypotensive Drugs and/or Vasoactive DrugsIf the patients' mean arterial pressure falls below 60 mmHg or 20% below the preoperative value, ephedrine will be administered. | Drug | – |
Primary outcome
postoperative edema and ecchymosis
Time frame: Each patient will be evaluated on postoperative days 1, 2 and 7.
Each patient will be photographed with a digital camera on postoperative days 1, 2, and 7. Eyelid edema and periorbital soft tissue ecchymosis will be assessed using a separate grading scale (range 0-4). The assessment will be performed by an independent observer for each patient on the indicated days.
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoplasty, run by Tokat Gaziosmanpasa 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 6 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 10 Mar 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?
postoperative edema and ecchymosis (time frame: Each patient will be evaluated on postoperative days 1, 2 and 7.). 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 10 Mar 2026.