Central Mammary Duct Excision; How to Improve the Outcome?

NCT ID: NCT04744766

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-01-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Duct Ectasia Breast Benign Breast Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Hadfield technique group

central/mammary duct excision is done by the ordinary method described by Hadfield

Group Type ACTIVE_COMPARATOR

major duct excision

Intervention Type PROCEDURE

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

Al Masad technique group

same procedure with de-epithelization of the upper pararaeolar area

Group Type ACTIVE_COMPARATOR

major duct excision

Intervention Type PROCEDURE

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

Interventions

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major duct excision

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

females with nipple discharge / recurrent peri-ductal mastitis

\-

Exclusion Criteria

* suspicion or evidence of malignancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud A. Alhussini, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine , Univeristy of Alexandria

Locations

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Faculty of Medicine, Main Univeristy Hospital

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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malhussini002

Identifier Type: -

Identifier Source: org_study_id

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