跳至主要内容
临床试验/NCT06014203
NCT06014203招募中不适用

Examination of Edema After Arthroscopic Shoulder Surgery

Gazi University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Edema

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arthroscopic shoulder surgery planned
  • 18-65 years old

排除标准

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

结局指标

主要结局

Edema

时间窗: 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.

次要结局

  • Surgery time(3 months)
  • Amount of the saline(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İnci Hazal Ayas

Principal Investigator

Gazi University

研究点 (1)

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