NCT07029750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 12, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

ObesityObstructive Sleep ApneaPulmonary FunctionLipoabdominoplasty

Outcome Measures

Primary Outcomes (7)

  • Forced Vital Capacity (FVC)

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

    8-10 minutes

  • 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.

    8-10 minutes

  • Peak Expiratory Flow (PEF)

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

    8-10 minutes

  • 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.

    8-10 minutes

  • 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.

    8-10 minutes

  • 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.

    8-10 minutes

  • 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.

    8-10 minutes

Study Arms (1)

Participants

Obese subjects undergoing lipoabdominoplasty

Procedure: Lipoabdominoplasty

Interventions

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.

Participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesitySleep Apnea, Obstructive

Interventions

Lipoabdominoplasty

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

AbdominoplastyCosmetic TechniquesTherapeuticsLipectomyBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Hikmet Ucgun, PT, PhD

    Atlas University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 19, 2025

Study Start

July 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations