Condition category
Cancer
Date applied
15/05/2005
Date assigned
12/09/2005
Last edited
30/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samir Hidar

ORCID ID

Contact details

71
rue Ch Kallala
Sousse
4011
Tunisia

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 measures

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

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

Sponsor information

Organisation

Farhat Hached University Teaching Hospital (Tunisia)

Sponsor details

Boulevard M. Karoui
Sousse
4001
Tunisia

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes