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

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 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: This prospective observational study will include adult patients (18-65 years) with a body mass index (BMI) over 30 kg/m² who are scheduled to undergo lipoabdominoplasty at a single tertiary care center. Eligible participants will be evaluated prior to surgery and again at 3 months postoperatively. Individuals with active pulmonary infections, chronic lung diseases, recent additional surgeries, or pregnancy will be excluded. All participants will provide written informed consent before enrollment. Approximately 24 participants are expected to complete both baseline and follow-up assessments.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Obesity, Obstructive Sleep Apnea

Being tested

Lipoabdominoplasty

Keywords

Obesity, Obstructive Sleep Apnea, Pulmonary Function, Lipoabdominoplasty

Medical subject headings

Obesity, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• LipoabdominoplastyProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Forced Vital Capacity (FVC)

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

   Measured: 8-10 minutes

2. Forced Expiratory Volume in 1 second (FEV1)

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

   Measured: 8-10 minutes

3. Peak Expiratory Flow (PEF)

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

   Measured: 8-10 minutes

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

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

   Measured: 8-10 minutes

5. mMRC Dyspnea Score

   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.

   Measured: 8-10 minutes

6. Sleep Apnea Risk Score

   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.

   Measured: 8-10 minutes

7. Obstructive Sleep Apnea Risk Score

   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.

   Measured: 8-10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Jun 2025
2. Study start1 Jul 2022
3. Primary completion1 Jan 2024
4. Study completion1 Jan 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for ObesityStudies of the same condition, open and under way.
• 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.