Back to resultsCentral Mammary Duct Excision; How to Improve the Outcome? (MDE)
Primary Purpose
Duct Ectasia Breast, Benign Breast Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
major duct excision
Sponsored by
About this trial
This is an interventional treatment trial for Duct Ectasia Breast
Eligibility Criteria
Inclusion Criteria:
females with nipple discharge / recurrent peri-ductal mastitis
-
Exclusion Criteria:
- suspicion or evidence of malignancy
Sites / Locations
- Faculty of Medicine, Main Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hadfield technique group
Al Masad technique group
Arm Description
central/mammary duct excision is done by the ordinary method described by Hadfield
same procedure with de-epithelization of the upper pararaeolar area
Outcomes
Primary Outcome Measures
patient satisfaction and sensation of nipple areolar complex complications
cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin
Secondary Outcome Measures
complications
eg nipple areolae complex (NAC) sensation, necrosis...etc
Full Information
NCT ID
NCT04744766
First Posted
February 4, 2021
Last Updated
February 4, 2021
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04744766
Brief Title
Central Mammary Duct Excision; How to Improve the Outcome?
Acronym
MDE
Official Title
Central Mammary Duct Excision; How to Improve the Outcome?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision
Detailed Description
first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duct Ectasia Breast, Benign Breast Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
the assessment of the results as regard the complication and long term follow up is done by a person who is blind as regard the study group of the patient examined
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hadfield technique group
Arm Type
Active Comparator
Arm Description
central/mammary duct excision is done by the ordinary method described by Hadfield
Arm Title
Al Masad technique group
Arm Type
Active Comparator
Arm Description
same procedure with de-epithelization of the upper pararaeolar area
Intervention Type
Procedure
Intervention Name(s)
major duct excision
Intervention Description
2 methods of major/central mammary duct excision are compared as regard the outcome
Primary Outcome Measure Information:
Title
patient satisfaction and sensation of nipple areolar complex complications
Description
cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
complications
Description
eg nipple areolae complex (NAC) sensation, necrosis...etc
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
females with nipple discharge / recurrent peri-ductal mastitis
-
Exclusion Criteria:
suspicion or evidence of malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud A. Alhussini, MD
Organizational Affiliation
Faculty of Medicine , Univeristy of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Main Univeristy Hospital
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Central Mammary Duct Excision; How to Improve the Outcome?
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