Examination of Edema After Arthroscopic Shoulder Surgery

Recruiting

• Conditions: Arthroscopy; Shoulder; Edema
• Interventions: Diagnostic Test: Edema measurement

• Registration Number: NCT06014203
• Lead Sponsor: Gazi University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-28
• Study Start: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Arthroscopic shoulder surgery planned
• 18-65 years old

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Edema	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Surgery time	3 months	The duration of each operation will be recorded in minutes by the surgeon performing the operation.
Amount of the saline	3 months	The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey