Examination of Edema After Arthroscopic Shoulder Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Edema; Shoulder; Arthroscopy
• Intervention / Treatment: Diagnostic test: Edema measurement

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: İnci H Ayas; Phone Number: 05071740342; Email: inciayass@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Gazi University
    • Contact: İnci H Ayas, Msc; Phone Number: (0312) 216 26 01; Email: inciayass@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology

Description

Inclusion Criteria:

• Arthroscopic shoulder surgery planned
• 18-65 years old

Exclusion Criteria:

• Frozen/stiff shoulder
• Metabolic and endocrine diseases
• Dermatological pathologies
• Hyperlaxity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing shoulder arthroscopy surgery; Patients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery time	The duration of each operation will be recorded in minutes by the surgeon performing the operation.	3 months
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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Ulunay Kanatlı, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 10, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Edema; Shoulder arthroscopy
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: Iayas5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No