An observational study in Rhinoplasty, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Tokat Gaziosmanpasa University · Observational
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.
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.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If the patients' mean arterial pressure falls below 60 mmHg or 20% below the preoperative value, ephedrine will be administered.
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.
Time frame: Each patient will be evaluated on postoperative days 1, 2 and 7.
Plan to share: Undecided
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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