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Not Yet Recruiting NCT07868562

Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty

Conditions: Abdominoplasty, Diaphragm, Respiratory Mechanics, Gastroesophageal Reflux Disease

Sex: Female
Ages: N/A – 60 Years
Healthy volunteers: Yes
Enrollment: 30
Sponsor: Universidade Federal de Pernambuco

Location: Departamento de Fisioterapia - UNIVERSIDADE FEDERAL DE PERNAMBUCO (UFPE) Recife Pernambuco

Summary

The objective of this observational study is to compare parameters of diaphragmatic mechanics, respiratory muscle function, and thoracoabdominal kinematics among women with gastroesophageal reflux disease (GERD) and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone, seeking to understand whether the association between these conditions is linked to greater impairment of respiratory function and thoracoabdominal dynamics. The main question the study aims to answer is: Do women with GERD and a history of abdominoplasty exhibit greater impairment of diaphragmatic mechanics compared to those with a history of abdominoplasty alone and those with GERD alone? Researchers will compare three groups of participants: women with GERD and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone to determine whether the coexistence of GERD and abdominoplasty is associated with greater alterations in diaphragmatic mobility and thickness, respiratory muscle strength and endurance, thoracoabdominal kinematics, abdominal core and sternocleidomastoid muscle thickness, and body composition, as well as worse GERD-related symptoms and quality of life. Participants will undergo an initial clinical assessment, including medical history, anthropometric measurements, and body composition analysis via bioimpedance. They will also complete questionnaires regarding GERD symptoms, quality of life, and physical activity levels. Subsequently, assessments will be performed, including ultrasound of the diaphragm, abdominal muscles, and sternocleidomastoid muscle; spirometry; evaluation of thoracoabdominal kinematics; measurement of respiratory muscle strength via manovacuometry; and a respiratory muscle endurance test. When necessary for the diagnostic confirmation of GERD, 24-hour ambulatory esophageal impedance-pH monitoring will be performed. Upon completion of the assessments, the results obtained will be compared across the three groups to identify potential differences related to the association between GERD and abdominoplasty.

Eligibility Criteria

Inclusion Criteria: * Female individuals aged ≥ 60 years with a body mass index (BMI) ≥ 30 kg/m². * Individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring and a history of abdominoplasty at least 10 years prior. * Individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring, without a history of abdominoplasty. * Individuals with a history of abdominoplasty at least 10 years prior, without symptoms suggestive of GERD and with no diagnosis of GERD. Exclusion Criteria: * Participants will be excluded if they have a hiatal hernia larger than 3 cm; * Chronic respiratory diseases capable of interfering with ventilatory mechanics (such as Chronic Obstructive Pulmonary Disease - COPD, Interstitial Lung Diseases - ILD, or severe asthma); * History of other thoracoabdominal surgeries; * Neuromuscular diseases; * Acute respiratory diseases within the last 30 days; * An inability to perform the proposed tests; * Pregnant.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07868562). StuddyBuddy aggregates publicly available trial information.