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Trial registered on ANZCTR


Registration number
ACTRN12615000440527
Ethics application status
Approved
Date submitted
28/03/2015
Date registered
7/05/2015
Date last updated
7/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of therapeutic mammoplasty techniques in surgical management of female patients with Idiopathic granulomatous mastitis in terms of recurrence and patients' satisfaction.
Scientific title
Evaluation of therapeutic mammoplasty techniques in surgical management of female patients with Idiopathic granulomatous mastitis in terms of recurrence and patients' satisfaction.
Secondary ID [1] 286437 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast inflammatory diseases 294610 0
Condition category
Condition code
Inflammatory and Immune System 294911 294911 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic mammoplasty starts by excision of the inflammatory mass with all infected tissue. Technique of closure of the defect will be tailored according to the site of the inflammatory mass according to each quadrant is as follows:
*Inflamatory mass at the upper half of the breast will be subjected to inferior pedicle therapeutic mammoplasty technique or round block.
*Inflamatory mass at the lower half of the breast will be subjected to superior pedicle therapeutic mammoplasty techniques and round block.
*Inflamatory mass at the periareolar region by Round block.
Regarding the contralateral breast, only patient with bra size C or D (10 patients) were offered contra-lateral reduction mammoplasty for symmetry and better esthetic result. Seven patients accepted while 3patients refused the procedure.
approximate duration of the procedure is 2 hours
Intervention code [1] 291514 0
Treatment: Surgery
Comparator / control treatment
simple excision and direct closure. Data was collected from previous researches (Azlina AF, Ariza Z, Arni T, Hisham AN: Chronic granulomatous mastitis: Diagnostic and therapeutic considerations. World J Surg 2003; 27:515–18. and Akcan A, Akyildiz H, Deneme MA, Akgun H, Aristas Y (2006) Granulomatous lobular mastitis: a complex diagnostic and therapeutic problem. World J Surg 30(8):1403–1409)
Excision and simple closure has been performed for a along time and still performed in some surgical centers.
Control group
Historical

Outcomes
Primary outcome [1] 294665 0
Recurrence
Timepoint [1] 294665 0
detected by the surgeon by clinical examination during visits in outpatients clinic at 1, 3, 6, 12,18 and 24 months. Recurrence was considered only after true-cut biopsy and histopathological confirmation.
Primary outcome [2] 294666 0
Patients’ satisfaction
Timepoint [2] 294666 0
by asking the patients to fill a premade questionnaire (KNUH breast reconstruction satisfaction questionnaire) during patients visit at 6 months after surgery. Each question was graded on a 5-point Likert scale ranging from “very satisfied [5]” to “very dissatisfied [1]” Then, each questionnaire was divided into two groups, with a rating of “satisfied” for mean scores >4 and “dissatisfied” for all other.
Secondary outcome [1] 313830 0
Operative time
Timepoint [1] 313830 0
measured (in minutes) by the operative nurse during the operation.
Secondary outcome [2] 313831 0
Early post operative complications (bleeding, early wound infection, seroma or diastasis of surgical wound)
Timepoint [2] 313831 0
detected by the doctor during the early post operative period and during patients visits at 14 days and one month after surgery.

Eligibility
Key inclusion criteria
Only patients with histopathological confirmation of Idiopathic granulomatous mastitis will be included in the study. Patients who have breast mass exceeding 20 % and less than 50% of the breast size with failed medical treatment (non decrease of mass size, severe pain from the mass that interfere with daily activity or intolerance to corticosteroid treatment) will be included in the study and will be offered surgical treatment. We used Bra Size as standard method for breast size while the size of the mass will be calculated clinically and radiologicaly.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients with known etiology of granulomatous mastitis will be excluded from the study. Patients who have breast mass less than 20 % or more than 50% of breast size will also be excluded from the study and will be offered alternative surgical option.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2010
Actual
10/07/2010
Date of last participant enrolment
Anticipated
Actual
12/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment outside Australia
Country [1] 6781 0
Egypt
State/province [1] 6781 0
Alexandria

Funding & Sponsors
Funding source category [1] 291007 0
Hospital
Name [1] 291007 0
Medical Research Institute
Country [1] 291007 0
Egypt
Primary sponsor type
Hospital
Name
Medical Research Institute
Address
Medical Research Institute
165 Al horreya street.
Al Hadarah
Alexandria
Postcode: 21526
Country
Egypt
Secondary sponsor category [1] 289685 0
None
Name [1] 289685 0
Address [1] 289685 0
Country [1] 289685 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56142 0
Dr Yaser Mahmoud Hamed MD, MRCS
Address 56142 0
Medical Research Institute
165 Al horreya street.
Al Hadarah
Alexandria
Postcode: 21526
Country 56142 0
Egypt
Phone 56142 0
+201224867866
Fax 56142 0
Email 56142 0
yasserendo30@yahoo.com
Contact person for public queries
Name 56143 0
Walid Abd El Maksoud MD, MRCS
Address 56143 0
department of general surgery
Alexandria Main University Hospital
1 kolleyet al teb street
Al Azareetah
College of medicine
University of Alexandria
Postcode: 21111
Country 56143 0
Egypt
Phone 56143 0
+201211433351
Fax 56143 0
Email 56143 0
dr.waleedmaksoud@gmail.com
Contact person for scientific queries
Name 56144 0
Walid Abd El Maksoud MD, MRCS
Address 56144 0
department of general surgery
Alexandria Main University Hospital
1 kolleyet al teb street
Al Azareetah
College of medicine
University of Alexandria
Postcode: 21111
Country 56144 0
Egypt
Phone 56144 0
+201211433351
Fax 56144 0
Email 56144 0
dr.waleedmaksoud@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.