Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000945224
Ethics application status
Approved
Date submitted
22/10/2009
Date registered
4/11/2009
Date last updated
4/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized clinical trial on the preservation of the medial pectoral nerve following mastectomy due to breast cancer: impact on upper limb rehabilitation
Scientific title
Randomized clinical trial on the preservation of the medial pectoral nerve following mastectomy due to breast cancer: impact on upper limb rehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 252044 0
Condition category
Condition code
Surgery 252234 252234 0 0
Surgical techniques
Physical Medicine / Rehabilitation 252252 252252 0 0
Physiotherapy
Cancer 252262 252262 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Group 1 (Comparator), 16 women, the medial pectoral nerve was preserved during the Patey´s mastectomy
duration of this procedure: mean 101,4 min
Intervention code [1] 241442 0
Treatment: Surgery
Intervention code [2] 241443 0
Rehabilitation
Comparator / control treatment
In Group 2 (Control): 14 women the medial pectoral nerve was sectioned during the Patey´s mastectomy. The routine Patey`s mastectomy procedure at this service is to section the medial pectoral nerve
duration of this procedure: mean 83,5 min
Control group
Active

Outcomes
Primary outcome [1] 253126 0
Preservation of the medial pectoral nerve and its association with no loss of strength in the pectoralis major muscle, compared with the group of women in whom this nerve was sectioned.

palpation of the pectoralis major muscle compared with sternal insertion was used to evaluate its trophism; and an overload test on the pectoralis major muscle was used to evaluate its strength.
Timepoint [1] 253126 0
Before surgery, 15 and 43 days after surgery
Secondary outcome [1] 257979 0
Loss of muscle mass in the pectoralis major muscle in women in the group with preservation of the medial pectoral nerve, compared with the group of women in whom this nerve was sectioned.

palpation of the pectoralis major muscle compared with sternal insertion was used to evaluate its trophism
Timepoint [1] 257979 0
Before surgery, 15 and 43 days after surgery
Secondary outcome [2] 258003 0
Differences between loss of range of shoulder flexion and abduction for the groups of women in whom the medial pectoral nerve was preserved or sectioned.

Goniometry was used to measure the range of movement of the upper limb;
Timepoint [2] 258003 0
Before surgery, 15 and 43 days after surgery

Eligibility
Key inclusion criteria
30 women with a histological diagnosis of breast cancer and an indication for modified mastectomy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were findings of limitations of movement in the homolateral upper limb at the preoperative evaluation; inability to understand the proposed exercises;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of the patients was done using sealed envelopes prepared by the computing section of the hospital. In 16 of these women, the medial pectoral nerve was preserved during the mastectomy, while in the remaining 14, this nerve was sectioned during surgery. The routine mastectomy procedure at this service is to section the medial pectoral nerve. To avoid contamination of the groups during the rehabilitation, the incision and consequently the scar was the same in both groups. The physiotherapist was blinded to the kind of surgery that had been performed and the patients were also not informed about the technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The sample size was estimated as 15 patients in each branch of the study. This was based on the study by Merson et al. which found that 54% of the women presented shoulder dysfunction after modified mastectomy with sectioning of the medial pectoralis nerve, while 6% presented shoulder dysfunction when the medial pectoralis nerve was preserved. Alpha and beta were estimated as 5% and 10%, respectively.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2289 0
Brazil
State/province [1] 2289 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 243913 0
University
Name [1] 243913 0
Universidade Estadual de Campinas (Unicamp), Campinas, Brazil
Country [1] 243913 0
Brazil
Primary sponsor type
University
Name
Universidade Estadual de Campinas (Unicamp), Campinas, Brazil
Address
Avenida Zeferino Vaz, s/n
Bairro: Cidade Universitaria
Campinas - Sao Paulo
CEP 13083 970
Country
Brazil
Secondary sponsor category [1] 251258 0
None
Name [1] 251258 0
Address [1] 251258 0
Country [1] 251258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244027 0
Institutional Review Board at the Department of Obstetrics and Gynecology, School of Medical Sciences, Universidade Estadual de Campinas (Unicamp), Campinas, Brazil.
Ethics committee address [1] 244027 0
Ethics committee country [1] 244027 0
Brazil
Date submitted for ethics approval [1] 244027 0
01/12/2001
Approval date [1] 244027 0
Ethics approval number [1] 244027 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30408 0
Address 30408 0
Country 30408 0
Phone 30408 0
Fax 30408 0
Email 30408 0
Contact person for public queries
Name 13655 0
Andrea de Vasconcelos Gonçalves
Address 13655 0
Rua Papa Leao XIII, no 10 casa 32
Real Parque
Campinas - Sao Paulo
Cep 13082 793
Country 13655 0
Brazil
Phone 13655 0
55 19 32890989
Fax 13655 0
Email 13655 0
[email protected]
Contact person for scientific queries
Name 4583 0
Andrea de Vasconcelos Gonçalves
Address 4583 0
Rua Papa Leao XIII, no 10 casa 32
Real Parque
Campinas - Sao Paulo
Cep 13082 793
Country 4583 0
Brazil
Phone 4583 0
55 19 32890989
Fax 4583 0
Email 4583 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.