Contact information
Type
Scientific
Primary contact
Dr Chintamani
ORCID ID
Contact details
DII/131
West Kidwai Nagar
New Delhi
110023
India
+91 (0)98 10064920
chintamani7@rediffmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
Group 1: 50 patients randomised to full vacuum suction (pressure = 700 g/m^2)
Group 2: 35 patients randomised to half vacuum suction (pressure = 350 g/m^2)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
85 fine needle aspiration cytology (FNAC) proven cases of locally advanced breast cancer were randomised into two groups. The groups were comparable in respect of age, weight and type of operation i.e. modified radical mastectomy (MRM)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
85
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
01/01/2003
Locations
Countries of recruitment
India
Trial participating centre
DII/131, West Kidwai Nagar
New Delhi
110023
India
Sponsor information
Organisation
Safdarjang Hospital - Vardhman Mahavir Medical College and Indian Council of Medical Research (India)
Sponsor details
-
New Delhi
110033
India
+91 (0)11 26268336 104
chintamani@doctor.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Institutions controlled by the government:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vardhman Mahavir Medical College, Safdarjang Hospital (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Indian Council Of Medical Research (India)
Alternative name(s)
ICMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
India
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15676064
Publication citations
-
Results
Chintamani, Singhal V, Singh J, Bansal A, Saxena S, Half versus full vacuum suction drainage after modified radical mastectomy for breast cancer- a prospective randomized clinical trial[ISRCTN24484328]., BMC Cancer, 2005, 5, 11, doi: 10.1186/1471-2407-5-11.