Condition category
Cancer
Date applied
18/01/2005
Date assigned
19/01/2005
Last edited
03/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes