Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-30 @ 12:44 AM
Study NCT ID:
NCT07029750
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077845', 'term': 'Lipoabdominoplasty'}], 'ancestors': [{'id': 'D061645', 'term': 'Abdominoplasty'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015187', 'term': 'Lipectomy'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '8-10 minutes', 'description': 'Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.'}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '8-10 minutes', 'description': 'Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': '8-10 minutes', 'description': 'Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.'}, {'measure': 'Forced Expiratory Flow 25-75% (FEF25-75)', 'timeFrame': '8-10 minutes', 'description': 'Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.'}, {'measure': 'mMRC Dyspnea Score', 'timeFrame': '8-10 minutes', 'description': '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.'}, {'measure': 'Sleep Apnea Risk Score', 'timeFrame': '8-10 minutes', 'description': "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."}, {'measure': 'Obstructive Sleep Apnea Risk Score', 'timeFrame': '8-10 minutes', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Obstructive Sleep Apnea', 'Pulmonary Function', 'Lipoabdominoplasty'], 'conditions': ['Obesity', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* BMI ≥ 30 kg/m²\n* Eligible for lipoabdominoplasty\n* Voluntary informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Active pulmonary infections or chronic lung disease\n* Additional surgical interventions during study period\n* Refusal to participate or incomplete data'}, 'identificationModule': {'nctId': 'NCT07029750', 'briefTitle': 'Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects', 'orgStudyIdInfo': {'id': 'auhucgun05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'Obese subjects undergoing lipoabdominoplasty', 'interventionNames': ['Procedure: Lipoabdominoplasty']}], 'interventions': [{'name': 'Lipoabdominoplasty', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hikmet Ucgun, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlas University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hikmet Ucgun', 'investigatorAffiliation': 'Atlas University'}}}}