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临床试验/NCT07029750
NCT07029750已完成不适用

Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects

Atlas University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Forced Vital Capacity (FVC)

研究概览

简要总结

This study investigates the long-term effects of lipoabdominoplasty on pulmonary function and obstructive sleep apnea (OSA) risk in obese patients. Participants were evaluated before and three months after surgery using spirometry, mMRC dyspnea scores, Epworth Sleepiness Scale (ESS), and STOP-Bang questionnaires.

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
否

入选标准

  • •Age ≥ 18 years
  • •BMI ≥ 30 kg/m²
  • •Eligible for lipoabdominoplasty
  • •Voluntary informed consent

排除标准

  • •Pregnancy
  • •Active pulmonary infections or chronic lung disease
  • •Additional surgical interventions during study period
  • •Refusal to participate or incomplete data

结局指标

主要结局

Forced Vital Capacity (FVC)

时间窗: 8-10 minutes

Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.

Forced Expiratory Volume in 1 second (FEV1)

时间窗: 8-10 minutes

Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.

Peak Expiratory Flow (PEF)

时间窗: 8-10 minutes

Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.

Forced Expiratory Flow 25-75% (FEF25-75)

时间窗: 8-10 minutes

Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.

mMRC Dyspnea Score

时间窗: 8-10 minutes

The dyspnea score will be assessed with the mMRC dyspnea score and is based on five stages of dyspnea caused by exertion and is scored between 0-4.

Sleep Apnea Risk Score

时间窗: 8-10 minutes

Sleep apnoea risk will be assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire that measures the subject's likelihood of falling asleep during daily activities. Higher scores reflect greater levels of daytime sleepiness and increased risk for conditions such as obstructive sleep apnoea.

Obstructive Sleep Apnea Risk Score

时间窗: 8-10 minutes

Obstructive sleep apnoea risk will be assessed assessed using the STOP-Bang questionnaire, an eight-item screening tool that evaluates snoring, tiredness, observed apnoea, high blood pressure, BMI, age, neck circumference, and gender. A higher score indicates a greater risk of OSA, with a cut-off of ≥3 commonly used to identify high-risk individuals.

次要结局

未报告次要终点

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hikmet Ucgun

Assistant Professor

Atlas University

研究点 (1)

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