Effect of Step Count on Edema After Rhinoplasty

NCT06202573 | Unknown

• 1 other identifier: rhino-step
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Reduce Edema and Ecchymosis After Rhinoplasty

Keywords

Rhinoplasty; edeme; ecchymosis; step count

Outcome Measures

Primary Outcomes (1)

• Effect of Step Count on Edema After Rhinoplasty

  prospective study

  6 months

Study Arms (5)

group1A

ACTIVE COMPARATOR

patients who have a step counter and we do not motivate them to walk

Procedure: rhinoplasty

Group 1B

ACTIVE COMPARATOR

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

Procedure: rhinoplasty

group 2

ACTIVE COMPARATOR

without step counter (only photos will be requested)

Procedure: rhinoplasty

group 3

ACTIVE COMPARATOR

patients with step counters whom we motivate to take at least 5000 steps

Procedure: rhinoplasty

group 4

ACTIVE COMPARATOR

patients with step counters whom we motivated to take at least 10000 steps

Procedure: rhinoplasty

Interventions

rhinoplasty PROCEDURE

patients who have a step counter and we do not motivate them to walk

Group 1B; group 2; group 3; group 4; group1A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of 3 research doctors (Dr. Salih Aydın, Dr. Timur Batmaz, Dr. Mehmet Erdil)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Salih aydın

Istanbul, 34510, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ecchymosis

Interventions

Rhinoplasty

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Nasal Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Salih Aydin, Prof.Dr.

  İstinye Medical Faculty, Otorhinolaryngology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

salih Aydin, prof.dr.

CONTACT

0905327776584; salih.aydin@istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: prospective randomised self-controlled clinical study

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: January 5, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)