- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06649370
Effect of Systemic Inflammatory Index and Systemic Immune Inflammation Index on Ecchymosis, Bleeding and Edema
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Center
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Tokat Province, Center, Turkey (Türkiye), 600100
- Tokat Gaziosmanpasa University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- Patients who are planning to undergo rhinoplasty and are between the ages of 18-45 are willing to participate in the study.
Exclusion Criteria:
- Heart failure
- Severe respiratory failure
- Renal failure
- Vascular diseases
- Steroid use
- Coagulation disorders.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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postoperative edema and ecchymosis
Time Frame: Each patient will be evaluated on postoperative days 1, 2 and 7.
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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.
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Each patient will be evaluated on postoperative days 1, 2 and 7.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-KAEK-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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