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Examination of Edema After Arthroscopic Shoulder Surgery

NCT ID: NCT06014203

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-05-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Edema Arthroscopy Shoulder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Edema measurement

Intervention Type DIAGNOSTIC_TEST

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:

1. Midpoint of the upper trapezius muscle
2. 5 cm distal to anterior acromion
3. 5cm distal to lateral acromion
4. 5cm distal to posterior acromion
5. 3cm medial to the axilla
6. Anterior cubital fossa
7. Carpal tunnel

Interventions

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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:

1. Midpoint of the upper trapezius muscle
2. 5 cm distal to anterior acromion
3. 5cm distal to lateral acromion
4. 5cm distal to posterior acromion
5. 3cm medial to the axilla
6. Anterior cubital fossa
7. Carpal tunnel

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Arthroscopic shoulder surgery planned
* 18-65 years old

Exclusion Criteria

* Frozen/stiff shoulder
* Metabolic and endocrine diseases
* Dermatological pathologies
* Hyperlaxity
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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İnci Hazal Ayas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulunay Kanatlı

Role: STUDY_DIRECTOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İnci H Ayas

Role: CONTACT

[email protected]
05071740342

Facility Contacts

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İnci H Ayas, MSc

Role: primary

[email protected]
(0312) 216 26 01

References

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Ayas IH, Akcan YO, Haspolat M, Tokgoz MA, Keser I, Kanatli U. Subcutaneous Pectoral Edema After Arthroscopic Labral Repair Despite Normal Irrigation Fluid Usage and Surgery Duration. Orthop Surg. 2025 Feb;17(2):624-630. doi: 10.1111/os.14324. Epub 2025 Jan 15.

Reference Type DERIVED
PMID: 39814377 (View on PubMed)

Other Identifiers

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Iayas5

Identifier Type: -

Identifier Source: org_study_id

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