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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06014203
Other study ID # Iayas5
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 10, 2024

Study information

Verified date March 2024
Source Gazi University
Contact Inci H Ayas
Phone 05071740342
Email inciayass@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators's aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline fluid is injected into the joint, depending on the duration of the surgery. The given fluid accumulates out of the joint in relation to the duration of the surgery and the amount of fluid given. In this study, the investigators aim is to examine how much the extra-articular fluid collects under the skin of the upper extremity and trunk, and the change in the amount of fluid 24 hours after surgery. Examination of the amount of subcutaneous fluid may help to better understand the postoperative complications such as edema, carpal tunnel syndrome, compartment syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are exposed to and its relationship with the duration of surgery can help to clinicians determine the safe discharge time.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 10, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Arthroscopic shoulder surgery planned - 18-65 years old Exclusion Criteria: - Frozen/stiff shoulder - Metabolic and endocrine diseases - Dermatological pathologies - Hyperlaxity

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Edema measurement
Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device. Points to be measured: Midpoint of the upper trapezius muscle 5 cm distal to anterior acromion 5cm distal to lateral acromion 5cm distal to posterior acromion 3cm medial to the axilla Anterior cubital fossa Carpal tunnel

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Edema After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis. 3 months
Secondary Surgery time The duration of each operation will be recorded in minutes by the surgeon performing the operation. 3 months
Secondary Amount of the saline The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation. 3 months
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