Abdominoplasty SurgeryNCT02762526
Lipoabdominoplasty and Diaphragmatic Mobility
An observational study of Abdominoplasty Surgery, run by Universidade Federal de Pernambuco.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty Surgery
- What is being tested?
- Lipoabdominoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing lipoabdominoplasty who meet the eligibility criteria for the search.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Repercussions of Lipoabdominoplasty Surgery on Diaphragmatic Mobility, Regional Distribution Ventilation of Thoracoabdominal System and Lung Function in Women Healthy.
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.
Read the 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.
- Conditions
- Abdominoplasty Surgery
- Being tested
- Lipoabdominoplasty
- Keywords
- lipectomy, abdominoplasty, plethysmography optoelectronics, diaphragmatic mobility, lung function, respiratory muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoabdominoplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility Diaphragmatic
Measure diaphragmatic mobility for total lung capacity maneuver
Measured: 30 days
plethysmography optoelectronics
measuring the change in lung volumes in the three compartments
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdominoplasty SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Fluhr Souto Barros, Universidade Federal de Pernambuco
- Investigators
- Daniella Araújo, PHD, Study chair, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762526
- Sponsor's protocol ID
- SF-6671649
- Status last verified
- May 2016
- First submitted
- 27 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 26895955Rodrigues 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.
PubMed 23982698Staalesen 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.
PubMed 22747350Tercan 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.
PubMed 12461445Perin 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.
PubMed 18693147Fluhr 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.
PubMed 31166554
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repercussions of Lipoabdominoplasty Surgery on Diaphragmatic Mobility, Regional Distribution Ventilation of Thoracoabdominal System and Lung Function in Women Healthy.
- ClinicalTrials.gov ID
- NCT02762526
- Acronym / sponsor ID
- SF-6671649
- Conditions
- Abdominoplasty Surgery
- Keywords
- lipectomy, abdominoplasty, plethysmography optoelectronics, diaphragmatic mobility, lung function, respiratory muscles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing lipoabdominoplasty who meet the eligibility criteria for the search.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoabdominoplasty | Procedure or surgery | – |
Primary outcome
Mobility Diaphragmatic
Time frame: 30 days
Measure diaphragmatic mobility for total lung capacity maneuver
plethysmography optoelectronics
Time frame: 30 days
measuring the change in lung volumes in the three compartments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Results publication: PubMed 26895955Pereira 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.
- Results publication: PubMed 23982698Rodrigues 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.
- Results publication: PubMed 22747350Staalesen 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.
- Results publication: PubMed 12461445Tercan 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.
- Results publication: PubMed 18693147Perin 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.
- Derived from this study: PubMed 31166554Fluhr 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniella Araújo, PHD study chair
UFPE
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominoplasty Surgery, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Fluhr, Specialist (+55 81 999222441, sandrafluhr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility Diaphragmatic (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762526, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.