Additional identifiers
EudraCT 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial 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
Phase
Not Specified
Drug names
NSAID
Primary outcome measure
Total volume drained after modified radical mastectomy
Secondary outcome measures
Breast surgery complications
Overall trial start date
01/04/2005
Overall trial 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
Patient
Age group
Adult
Gender
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
Trial participating centre
71, rue Ch Kallala
Sousse
4011
Tunisia
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results:
Influence of Ketoprofen on drainage volume after radical breast cancer surgery: A prospective randomized clinical trial [ISRCTN06628870] JTGGA 2007; 8 - 1 | Pages 71 - 75
Samir Hidar, Khadija Soussi, Mohamed Bibi, Hédi Khaïri
Abstract: http://www.jtgga.org/jvi.asp?pdir=jtgga&plng=eng&un=JTGGA-57441&look4=hidar%20S
Full Text Article In English: http://www.journalagent.com/z4/download_fulltext.asp?pdir=jtgga&plng=eng&un=JTGGA-57441