NCT02762526

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Status
unknown

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

First Submitted

Initial submission to the registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

April 27, 2016

Last Update Submit

May 2, 2016

Conditions

Keywords

lipectomyabdominoplastyplethysmography optoelectronicsdiaphragmatic mobilitylung functionrespiratory muscles

Outcome Measures

Primary Outcomes (2)

  • Mobility Diaphragmatic

    Measure diaphragmatic mobility for total lung capacity maneuver

    30 days

  • plethysmography optoelectronics

    measuring the change in lung volumes in the three compartments

    30 days

Interventions

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing lipoabdominoplasty who meet the eligibility criteria for the search.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

Related Links

MeSH Terms

Interventions

Lipoabdominoplasty

Intervention Hierarchy (Ancestors)

AbdominoplastyCosmetic TechniquesTherapeuticsLipectomyBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Daniella Araújo, PHD

    UFPE

    STUDY CHAIR

Central Study Contacts

Sandra Fluhr, Specialist

CONTACT

Daniella Brandão, PHD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05