Central Mammary Duct Excision; How to Improve the Outcome? (MDE)

February 4, 2021 updated by: Alexandria University
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine, Main Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

females with nipple discharge / recurrent peri-ductal mastitis

-

Exclusion Criteria:

  • suspicion or evidence of malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hadfield technique group
central/mammary duct excision is done by the ordinary method described by Hadfield
Procedure: major duct excision
2 methods of major/central mammary duct excision are compared as regard the outcome
ACTIVE_COMPARATOR: Al Masad technique group
same procedure with de-epithelization of the upper pararaeolar area
Procedure: major duct excision
2 methods of major/central mammary duct excision are compared as regard the outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction and sensation of nipple areolar complex complications
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 6 months
eg nipple areolae complex (NAC) sensation, necrosis...etc
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mahmoud A. Alhussini, MD, Faculty of Medicine , Univeristy of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

January 27, 2021

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (ACTUAL)

February 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • malhussini002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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