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NCT04744766 Clinical Trial

Central Mammary Duct Excision; How to Improve the Outcome?

Benign Breast Disease Clinical Trial

— MDE  

Official title:
Central Mammary Duct Excision; How to Improve the Outcome?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04744766
Other study ID # malhussini002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 27, 2021

Study information
Verified date January 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date January 27, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: females with nipple discharge / recurrent peri-ductal mastitis - Exclusion Criteria: - suspicion or evidence of malignancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• major duct excision
2 methods of major/central mammary duct excision are compared as regard the outcome

Locations
Country Name City State
Egypt Faculty of Medicine, Main Univeristy Hospital Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary complications eg nipple areolae complex (NAC) sensation, necrosis...etc 6 months
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