Non-steroidal anti-inflammatory drug (NSAID) use in breast surgery: prospective randomised trial

ISRCTN ISRCTN06628870
DOI https://doi.org/10.1186/ISRCTN06628870
Secondary identifying numbers N/A
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

71, rue Ch Kallala
Sousse
4011
Tunisia

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesModification of drainage volume after NSAID administration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionBefore entering operating room for breast cancer patients are randomised into two groups:
1. NSAID
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)NSAID
Primary outcome measureTotal volume drained after modified radical mastectomy
Secondary outcome measuresBreast surgery complications
Overall study start date01/04/2005
Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100
Key inclusion criteriaEligible patienst are women with a breast cancer undergoing modified radical mastectomy
Key exclusion criteria1. Known allergy or contraindication to NSAID
2. Planned immediate or late breast reconstruction
Date of first enrolment01/04/2005
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • Tunisia

Study participating centre

71, rue Ch Kallala
Sousse
4011
Tunisia

Sponsor information

Farhat Hached University Teaching Hospital (Tunisia)
Hospital/treatment centre

Boulevard M. Karoui
Sousse
4001
Tunisia

ROR logo "ROR" https://ror.org/0059hys23

Funders

Funder type

Hospital/treatment centre

Farhat Hached University Teaching Hospital (Tunisia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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