NCT04744766

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

February 4, 2021

Last Update Submit

February 4, 2021

Conditions

Duct Ectasia BreastBenign Breast Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • complications

    6 months

Study Arms (2)

Hadfield technique group

ACTIVE COMPARATOR

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

Procedure: major duct excision

Al Masad technique group

ACTIVE COMPARATOR

same procedure with de-epithelization of the upper pararaeolar area

Procedure: major duct excision

Interventions

major duct excisionPROCEDURE

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

Al Masad technique groupHadfield technique group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • females with nipple discharge / recurrent peri-ductal mastitis

You may not qualify if:

  • suspicion or evidence of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Main Univeristy Hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Mahmoud A. Alhussini, MD

    Faculty of Medicine , Univeristy of Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

January 27, 2021

Last Updated

February 9, 2021

Record last verified: 2021-01

Locations

EG(1)