Examination of Edema After Arthroscopic Shoulder Surgery

Sponsor
Gazi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06014203
Collaborator
(none)
100
3

Study Details

Study Description

Brief Summary

Our 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, our 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 us determine the safe discharge time.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Edema measurement

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Examination of Edema After Arthroscopic Shoulder Surgery
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Surgery time [3 months]

    The duration of each operation will be recorded in minutes by the surgeon performing the operation.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Arthroscopic shoulder surgery planned

  • 18-65 years old

Exclusion Criteria:
  • Frozen/stiff shoulder

  • Metabolic and endocrine diseases

  • Dermatological pathologies

  • Hyperlaxity

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gazi University

Investigators

  • Study Director: Ulunay Kanatlı, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
İnci Hazal Ayas, Research asistant (PT), Gazi University
ClinicalTrials.gov Identifier:
NCT06014203
Other Study ID Numbers:
  • Iayas5
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by İnci Hazal Ayas, Research asistant (PT), Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023