EdemaNCT06014203
Examination of Edema After Arthroscopic Shoulder Surgery
An observational study of Edema and Arthroscopy, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edema, Arthroscopy, Shoulder
- What is being tested?
- Edema measurement
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 10 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology
Who may be able to join
- Arthroscopic shoulder surgery planned
- 18-65 years old
Who cannot join
- Frozen/stiff shoulder
- Metabolic and endocrine diseases
- Dermatological pathologies
- Hyperlaxity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, 06560
İnci H Ayas, MSc, (0312) 216 26 01, inciayass@gmail.com
About this study
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.
- Conditions
- Edema, Arthroscopy, Shoulder
- Being tested
- Edema measurement
- Keywords
- Edema, Shoulder arthroscopy
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edema measurementDiagnostic 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:
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Edema measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Surgery time
The duration of each operation will be recorded in minutes by the surgeon performing the operation.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Ulunay Kanatlı, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014203
- Sponsor's protocol ID
- Iayas5
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 39814377
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Edema After Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06014203
- Acronym / sponsor ID
- Iayas5
- Conditions
- Edema, Arthroscopy, Shoulder
- Keywords
- Edema, Shoulder arthroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing shoulder arthroscopy surgery | – | Diagnostic Test: Edema measurementPatients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology
Key inclusion criteria (2 listed)
- Arthroscopic shoulder surgery planned
- 18-65 years old
Key exclusion criteria (4 listed)
- Frozen/stiff shoulder
- Metabolic and endocrine diseases
- Dermatological pathologies
- Hyperlaxity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edema measurementSubcutaneous 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 | Diagnostic test | Patients undergoing shoulder arthroscopy surgery |
Primary outcome
Edema
Time frame: 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.
2 secondary outcomes
Surgery time
Time frame: 3 months
Amount of the saline
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 39814377Ayas 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulunay Kanatlı study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema and Arthroscopy, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İnci H Ayas (05071740342, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06014203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.