Non-steroidal anti-inflammatory drug (NSAID) use in breast surgery: prospective randomised trial
| ISRCTN | ISRCTN06628870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06628870 |
| Protocol serial number | N/A |
| Sponsor | Farhat Hached University Teaching Hospital (Tunisia) |
| Funder | Farhat Hached University Teaching Hospital (Tunisia) |
- Submission date
- 15/05/2005
- Registration date
- 12/09/2005
- Last edited
- 30/07/2008
- 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 Samir Hidar
Scientific
Scientific
71, rue Ch Kallala
Sousse
4011
Tunisia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Modification of drainage volume after NSAID administration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Before entering operating room for breast cancer patients are randomised into two groups: 1. NSAID 2. Placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | NSAID |
| Primary outcome measure(s) |
Total volume drained after modified radical mastectomy |
| Key secondary outcome measure(s) |
Breast surgery complications |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | Eligible patienst are women with a breast cancer undergoing modified radical mastectomy |
| Key exclusion criteria | 1. Known allergy or contraindication to NSAID 2. Planned immediate or late breast reconstruction |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
4011
Tunisia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Abstract: | 17/11/2006 | No | No |
