Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001593581 Date of Approval: 17/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spared healthy breast tissue after Breast Conserving Surgery
Official scientific title Spared healthy breast tissue after Breast Conserving Surgery for palpable invasive ductal breast carcinoma; US guided versus Traditional palpation guided excision.
Brief summary describing the background and objectives of the trial Breast is still the commonest site of cancer in females. Breast Conserving Surgery is providing long term survival equal to that seen with mastectomy for early stage breast cancer. Wider free resection margin don¿t significantly lower risk of local recurrence. Objectives The aim of the study was to compare between US guided versus Traditional palpation guided excision in Breast Conserving Surgery for palpable invasive ductal breast carcinoma regarding the volume of spared healthy breast tissue.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 17/04/2013
Actual trial start date 17/04/2013
Anticipated date of last follow up 17/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Breast Conserving Surgery Breast Conserving Surgery excision. 20
Experimental Group Breast Conserving Surgery Traditional palpation guided excision. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were chosen for the study if they have biopsy proven invasive ductal carcinoma of the breast, stage T1 or T2 The cases showed positive resection margin on histopathological examination were undergone resurgery and excluded from this study 27 Year(s) 62 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2014 banha university
Ethics Committee Address
Street address City Postal code Country
bahna fareed nada street banha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome volume of healthy breast tissue spared histopathology. flask
Secondary Outcome more cosmetic breast volume
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
banha university hospital banha fareed nada street banha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal authors banha fareed nada street banha 13518 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor banha university hospital banha fareed nada street banha 13518 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
personal authors banha fareed nada street banha 13518 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hussein elgohary dr_elgohary1996@yahoo.com 01113543824 banha fareed nada street
City Postal code Country Position/Affiliation
banha 13518 Egypt Assistant professor of general surgery, faculty of medicine, Benha University
Role Name Email Phone Street address
Public Enquiries ehab oraby ehaborabyy@yahoo.com 01003783425 banha fareed nada street
City Postal code Country Position/Affiliation
banha 13518 Egypt Lecturer of general surgery, faculty of medicine, Benha University
Role Name Email Phone Street address
Scientific Enquiries ahmed zidan dr_ahmedtorky@yahoo.com 01227416535 banha fareed nada street
City Postal code Country Position/Affiliation
banha 13518 Egypt Assistant professor of general surgery, faculty of medicine, Benha University.
REPORTING
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Result URL Hyperlinks
Changes to trial information