Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000271303
Ethics application status
Approved
Date submitted
17/05/2008
Date registered
29/05/2008
Date last updated
1/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial to compare three surgical techniques to reduce the formation of seromas after breast cancer surrgery
Scientific title
Reducing Seroma Formation After Axillary Lymph Node Dissection: A Comparative Study Of Three Methods
Secondary ID [1] 837 0
NCTRI No.and Date
CTRI/2008/091/000058, 11-12-2008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seroma formation after Axillary Lymph Node Dissection(ALND) for breast cancer surgery 3168 0
Condition category
Condition code
Surgery 3324 3324 0 0
Surgical techniques
Cancer 3325 3325 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. External compression dressings for one week
2. Suturing of flaps
Intervention code [1] 2897 0
Treatment: Surgery
Comparator / control treatment
Closed suction drain(drains are kept in place for 7-14 days)
Control group
Historical

Outcomes
Primary outcome [1] 4212 0
Incidence of Seroma formation
Timepoint [1] 4212 0
45 days
Secondary outcome [1] 7127 0
daily and total volume of drain output
Timepoint [1] 7127 0
45 days
Secondary outcome [2] 7128 0
number and frequencies of aspirations
Timepoint [2] 7128 0
45 days

Eligibility
Key inclusion criteria
Female patients of age 30 to 75
Biopsy/Fine needle Aspiration cytology(FNAC) proven carcinoma breast.
Patients undergoing axillary lymph node dissection as part of surgical treatment for breast cancer
Availability for follow up for at least one month after surgery
Minimum age
30 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgical procedures in and around the axilla
Bilateral breast cancer
Simultaneous reconstructive surgery.
Pregnant and lactating women.
Chronic shoulder or limb pathology,
Other serious underlying medical illness(es) precluding full study participation

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)
Each patient enrolled in the study will be given a serial number and will be randomized in blocks to one of the three groups. (One control + two study groups)
Group 1. Closed suction drain group (Control group)
Group 2. External compression dressing group
Group 3. Mechanical flap closure group

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random list of blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 970 0
India
State/province [1] 970 0
Chandigarh

Funding & Sponsors
Funding source category [1] 3392 0
Hospital
Name [1] 3392 0
Post Graduate Institute of Medical Education and Research
Country [1] 3392 0
India
Primary sponsor type
Hospital
Name
Post Graduate Institute of Medical Education and Research
Address
Post Graduate Institute of Medical Education and Research
Chandigarh
India
160012
Country
India
Secondary sponsor category [1] 3037 0
None
Name [1] 3037 0
Address [1] 3037 0
Country [1] 3037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5424 0
Institute Ethics Committee,PGIMER,Chandigarh, India
Ethics committee address [1] 5424 0
Ethics committee country [1] 5424 0
India
Date submitted for ethics approval [1] 5424 0
Approval date [1] 5424 0
27/09/2007
Ethics approval number [1] 5424 0

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

Contacts
Principal investigator
Name 28598 0
Address 28598 0
Country 28598 0
Phone 28598 0
Fax 28598 0
Email 28598 0
Contact person for public queries
Name 11755 0
Dr. K.S.Rajkumar
Address 11755 0
Junior Resident
Dept. of General Surgery
PGIMER
Chandigarh
160012
Country 11755 0
India
Phone 11755 0
+919855457101
Fax 11755 0
Email 11755 0
drksrajkumar@gmail.com
Contact person for scientific queries
Name 2683 0
Dr. K.S.Rajkumar
Address 2683 0
Junior Resident
Dept. of General Surgery
PGIMER
Chandigarh
160012
Country 2683 0
India
Phone 2683 0
+919855457101
Fax 2683 0
Email 2683 0
drksrajkumar@gmail.com

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.