Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Modification of drainage volume after NSAID administration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
Before entering operating room for breast cancer patients are randomised into two groups:
1. NSAID
2. Placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
NSAID
Primary outcome measure
Total volume drained after modified radical mastectomy
Secondary outcome measures
Breast surgery complications
Overall study start date
01/04/2005
Overall study end date
30/11/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Eligible patienst are women with a breast cancer undergoing modified radical mastectomy
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
100
Participant exclusion criteria
1. Known allergy or contraindication to NSAID
2. Planned immediate or late breast reconstruction
Recruitment start date
01/04/2005
Recruitment end date
30/11/2005
Locations
Countries of recruitment
Tunisia
Study participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
Sponsor information
Organisation
Farhat Hached University Teaching Hospital (Tunisia)
Sponsor details
Boulevard M. Karoui
Sousse
4001
Tunisia
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Farhat Hached University Teaching Hospital (Tunisia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Abstract: | 17/11/2006 | No | No |