Central Mammary Duct Excision; How to Improve the Outcome?

Not Applicable

Completed

• Conditions: Duct Ectasia Breast; Benign Breast Disease
• Interventions: Procedure: major duct excision

• Registration Number: NCT04744766
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-01
• Study Completion: 2021-01-27
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Last Update Submitted: 2021-02-04
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

females with nipple discharge / recurrent peri-ductal mastitis

Exclusion Criteria

• suspicion or evidence of malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hadfield technique group	major duct excision	central/mammary duct excision is done by the ordinary method described by Hadfield
Al Masad technique group	major duct excision	same procedure with de-epithelization of the upper pararaeolar area

Primary Outcome Measures

Name	Time	Method
patient satisfaction and sensation of nipple areolar complex complications	6 months	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

Name	Time	Method
complications	6 months	eg nipple areolae complex (NAC) sensation, necrosis...etc

Trial Locations

Locations (1)

Faculty of Medicine, Main Univeristy Hospital; 🇪🇬 Alexandria, Egypt