Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000904875
Ethics application status
Approved
Date submitted
21/12/2008
Date registered
24/08/2012
Date last updated
24/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of mammary reduction surgery in women with macromastia in respiratory system impedance and pulmonary function
Scientific title
Effect of mammary reduction in the pulmonary function and mechanics for healthy women with macromastia: Intra and post-operative evaluation
Secondary ID [1] 281071 0
NiL
Universal Trial Number (UTN)
U1111-1133-7292
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We are evaluating healthy women with macromastia that will be submitted to mammary reduction 4150 0
All patients have macromastia and are in level I of American Society of Anesthesiologist (ASA) classification. 287222 0
Macromastia has an impact on orthopedic problems. We will evaluate the impact of macromastia and mammary reduction over respiratory system. 287223 0
Condition category
Condition code
Surgery 4358 4358 0 0
Other surgery
Respiratory 4359 4359 0 0
Normal development and function of the respiratory system
Anaesthesiology 287546 287546 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The measuring of compliance and oxygenation were carried out in four stages. After 10 minutes of mechanical ventilation, before the start of surgery, static compliance was measured and hemogasometry was carried out. Immediately after the first stage, a recruitment maneuver was applied and 10 minutes later static compliance was measured and hemogasometry was carried out to complete the second stage. At the end of the surgery, static compliance was measured and hemogasometry was carried out again. Then a new recruitment maneuver was applied to complete the third stage. Ten minutes later, static compliance was measured and hemogasometry was carried out to complete the fourth stage. The mammary reduction was made by bilateral resection of the breast - super-medial, pediculo's technique which is used normally to reduce the breast symmetrically. The lung and the chest have a impedance which can be measured by the compliance and resistence. The reduction of the breast was measured by the weight and the respiratory system impedance was measured with a inspiratory pause at the respirator. Every surgery had a mean of 270 minutes.
Intervention code [1] 3868 0
Treatment: Surgery
Comparator / control treatment
Not applicable as this is a single group study.

All patients are a self control comparison. The measuring will be compared at the beginning, half and the end of the surgery.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287810 0
The respiratory system impedance were assessed by the respirator with a inspiratory pause in volume-controlled ventilation mode by a physical therapist. The partial pressure of O2 and Co2 were assessed by the gas analyzers
Timepoint [1] 287810 0
Measure of respiratory system impedance and partial pressure of O2 and Co2
1- After the intubation
2- After 60 minutes of surgery
3- After 120 minutes of surgery
4- At the end of surgery
Secondary outcome [1] 298868 0
Quality of Life. We evaluated the quality of life with SF-36 questionnaire before and after the surgery. The questionnaire was applied by the researcher.
Timepoint [1] 298868 0
The questionnaire was applied before the surgery at the first consult and 3 months after the surgery.

Eligibility
Key inclusion criteria
Patients with macromastia and physical status by American Society of Anesthesiology (ASA) = 1
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with ASA > 1
Patients classified with difficult airway
Patients with Allen test positive
Patients with active disease in respiratory system

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with macromastia and was in ASA 1 were enrolled to the trial.

All patients acted as their own controls. We evaluated the respiratory impedance system impedance before and after de mammary reduction surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 1482 0
Brazil
State/province [1] 1482 0
Bahia

Funding & Sponsors
Funding source category [1] 4321 0
University
Name [1] 4321 0
Federal University of Bahia
Country [1] 4321 0
Brazil
Primary sponsor type
Hospital
Name
Professor Edgard Santos University Hospital
Address
Augusto Viana Street, Canela / ZIP CODE 40110-060.
Salvador / Bahia
Country
Brazil
Secondary sponsor category [1] 284693 0
None
Name [1] 284693 0
Address [1] 284693 0
Country [1] 284693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287896 0
Federal University of Bahia
Ethics committee address [1] 287896 0
Augusto Viana Street, Canela, Salvador.

ZIP Code: 40.110-060
Ethics committee country [1] 287896 0
Brazil
Date submitted for ethics approval [1] 287896 0
01/04/2004
Approval date [1] 287896 0
02/11/2004
Ethics approval number [1] 287896 0
78/2005

Summary
Brief summary
Patients with macromastia were submitted to mammary reduction and we assessed the impact of this procedure in respiratory system impedance. We hypothesized that this reduction could improve the respiratory system impedance. All patients were recruited in Brazil.
Trial website
No
Trial related presentations / publications
No
Public notes

Contacts
Principal investigator
Name 35055 0
Address 35055 0
Country 35055 0
Phone 35055 0
Fax 35055 0
Email 35055 0
Contact person for public queries
Name 12402 0
Paulo Eugenio Silva
Address 12402 0
Rio Tocantins Street 11, Recanto das Arvores, Irece Bahia.
ZIP Code 44900-000
Country 12402 0
Brazil
Phone 12402 0
+55,74,99981915
Fax 12402 0
Email 12402 0
[email protected]
Contact person for scientific queries
Name 3330 0
Paulo Eugenio Silva
Address 3330 0
Rio Tocantins Street 11, Recanto das Arvores
City: Irece

ZIP Code 44900-000
Country 3330 0
Brazil
Phone 3330 0
+55,74,99981915
Fax 3330 0
Email 3330 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.