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Clinical Trials/NCT07029750
NCT07029750CompletedNot Applicable

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

Atlas University1 site in 1 country24 target enrollmentStarted: July 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Forced Vital Capacity (FVC)

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Forced Vital Capacity (FVC)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Atlas University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hikmet Ucgun

Assistant Professor

Atlas University

Study Sites (1)

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