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Completed

NCT Number: NCT07029750

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

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.

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Key information

Conditions

Obesity Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obstructive Sleep Apnea Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipoabdominoplasty

Procedure

Combination of liposuction and abdominoplasty under general anesthesia. Klein solution used for tumescent liposuction. Muscle plication performed with 0 loop polydioxanone suture. Umbilicus preserved and repositioned. Postoperative compression corset used for 1 month.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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