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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02762526
Other study ID # SF-6671649
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 27, 2016
Last updated May 2, 2016
Start date May 2016
Est. completion date May 2016

Study information

Verified date May 2016
Source Universidade Federal de Pernambuco
Contact Sandra Fluhr, Specialist
Phone +55 81 999222441
Email sandrafluhr@hotmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

Background: 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 undergoing such procedures. Objective: 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. Methods: This is a prospective cohort study, which will be evaluated 30 women aged 25 to 55 years undergoing lipoabdominoplasty surgery without respiratory or prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2. women smokers are deleted and / or a history of smoking more than 10 years and unable to understand the commands to perform the proposed methods. For evaluation of diaphragmatic mobility will be used high-resolution ultrasound with convex 3.5 MHz transducer. The evaluation 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. Hypotheses: 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 55 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Lipoabdominoplasty


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

References & Publications (5)

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 Feb 9. pii: sjv273. [Epub ahead of print] — View Citation

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. — View Citation

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/s00266-0 — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mobility Diaphragmatic Measure diaphragmatic mobility for total lung capacity maneuver 30 days Yes
Primary plethysmography optoelectronics measuring the change in lung volumes in the three compartments 30 days Yes

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