- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762526
Lipoabdominoplasty and Diaphragmatic Mobility
Repercussions of Lipoabdominoplasty Surgery on Diaphragmatic Mobility, Regional Distribution Ventilation of Thoracoabdominal System and Lung Function in Women Healthy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
The lipoabdominoplasty can lead to respiratory complications in the postoperative period becoming critical early clinical and functional evaluation of respiratory muscles, seeking to direct a more effective treatment, which can result in shorter hospital stays and lower spending on health in patients subjected to this type of procedure.
hypotheses: Patients undergoing lipoabdominoplasty surgery with muscular plication, have decreased diaphragmatic mobility, strength and respiratory function, in addition to presenting changes in the regional distribution pattern of ventilation in torocoabdominal system in the postoperative period when compared to the preconditions surgery .
Goal:
To evaluate the correlation of regional distribution of ventilation system with thoracoabdominal diaphragmatic mobility in women undergoing surgery lipoabdominoplasty comparing preoperative, 10 ° and 30 ° DPO DPO.
Hypothesis:
Patients undergoing surgery lipoabdominoplasty have decreased diaphragmatic mobility, strength and respiratory function, in addition to presenting changes in the pattern of regional ventilation distribution in torocoabdominal system in the postoperative period when compared to the preconditions surgery.
Materials and methods:
This is a prospective cohort study, which will be evaluated 30 women between 30 and 50 years underwent surgery lipoabdominoplasty without respiratory or prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2. women smokers are deleted and / or a history of smoking greater than 10 years, FEV1 <80% predicted, FEV1 / FVC <70% of predicted and unable to understand the commands to perform the proposed methods. For evaluation of diaphragmatic mobility and thickness will be used high-resolution ultrasound with a convex transducer of 3.5 MHz and 7.5 MHz linear transducer, respectively. The assessment of the regional distribution of ventilation thoracoabdominal system will be made using the optoelectronic plethysmograph (POE). The strength of the inspiratory and expiratory muscles is measured through a digital manometer connected to a nozzle with an orifice of 2 mm to reduce the closing pressure of the glottis. A portable spirometer is used for assessment of pulmonary function and evaluation of dyspnea will be used modified Borg scale. The data will be evaluated in the preoperative period, 10 days and 30 days postoperatively.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- women will be included between 25 and 55 years underwent surgery lipoabdominoplasty without respiratory or prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2.
Exclusion Criteria:
- women smokers will be deleted and / or a history of smoking more than 10 years; FEV1 <80% predicted and FEV1 / FVC <70% of predicted; unable to understand the commands to perform the proposed methods.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility Diaphragmatic
Time Frame: 30 days
|
Measure diaphragmatic mobility for total lung capacity maneuver
|
30 days
|
|
plethysmography optoelectronics
Time Frame: 30 days
|
measuring the change in lung volumes in the three compartments
|
30 days
|
Collaborators and Investigators
Investigators
- Study Chair: Daniella Araújo, PHD, UFPE
Publications and helpful links
General Publications
- Pereira N, Sciaraffia C, Danilla S, Parada F, Asfora C, Moral C. Effects of Abdominoplasty on Intra-Abdominal Pressure and Pulmonary Function. Aesthet Surg J. 2016 Jun;36(6):697-702. doi: 10.1093/asj/sjv273. Epub 2016 Feb 9.
- Rodrigues MA, Nahas FX, Gomes HC, Ferreira LM. Ventilatory function and intra-abdominal pressure in patients who underwent abdominoplasty with plication of the external oblique aponeurosis. Aesthetic Plast Surg. 2013 Oct;37(5):993-9. doi: 10.1007/s00266-013-0158-5. Epub 2013 Aug 27.
- Staalesen T, Elander A, Strandell A, Bergh C. A systematic review of outcomes of abdominoplasty. J Plast Surg Hand Surg. 2012 Sep;46(3-4):139-44. doi: 10.3109/2000656X.2012.683794. Epub 2012 Jul 2.
- Tercan M, Bekerecioglu M, Dikensoy O, Kocoglu H, Atik B, Isik D, Tercan A. Effects of abdominoplasty on respiratory functions: a prospective study. Ann Plast Surg. 2002 Dec;49(6):617-20. doi: 10.1097/00000637-200212000-00011.
- Perin LF, Saad R Jr, Stirbulov R, Helene A Jr. Spirometric evaluation in individuals undergoing abdominoplasty. J Plast Reconstr Aesthet Surg. 2008 Nov;61(11):1392-4. doi: 10.1016/j.bjps.2008.02.028. Epub 2008 Aug 8. No abstract available.
- Fluhr S, Andrade AD, Oliveira EJB, Rocha T, Medeiros AIC, Couto A, Maia JN, Brandao DC. Lipoabdominoplasty: repercussions for diaphragmatic mobility and lung function in healthy women. J Bras Pneumol. 2019 May 30;45(3):e20170395. doi: 10.1590/1806-3713/e20170395.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SF-6671649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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