Half versus full suction drainage after mastectomy for breast cancer
| ISRCTN | ISRCTN24484328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24484328 |
| Protocol serial number | N/A |
| Sponsor | Safdarjang Hospital - Vardhman Mahavir Medical College and Indian Council of Medical Research (India) |
| Funders | Institutions controlled by the government:, Vardhman Mahavir Medical College, Safdarjang Hospital (India), Indian Council Of Medical Research (India) |
- Submission date
- 18/01/2005
- Registration date
- 19/01/2005
- Last edited
- 03/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chintamani
Scientific
Scientific
DII/131, West Kidwai Nagar
New Delhi
110023
India
| Phone | +91 (0)98 10064920 |
|---|---|
| chintamani7@rediffmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Target sample size at registration | 85 |
| Key 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) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- India
Study participating centre
DII/131, West Kidwai Nagar
New Delhi
110023
India
110023
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 27/01/2005 | Yes | No |
