- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064215
Lymphatic Drainage of the Breast, a Retrospective Assessment of Data
September 21, 2021 updated by: Dr. Elisabeth Würinger
retrospective evaluation of patients, in whom blue colour was injected into different sites of the breast before breast reduction, to investigate direction and localisation of lymphatic flow.
Investigations were performed at the Wilhelminenspital, Vienna, in the years 1998 to 2009.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
14
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
-
-
Österreich
-
Wien, Österreich, Austria, 1130
- Elisabeth Wuringer
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients, who were operated on breast reduction
Description
Inclusion Criteria: Patients, who understood and supported the aim of the study and signed the written consent -
Exclusion Criteria: language barriers, patients, who did not understand and support the aim of the study
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
injection behind NAC
in 7 breasts dye was injected behind the nipple areola complex before breast reduction
|
After injection of dye, its distribution along lymphatic clearance paths was investigated
|
Injection into lateral upper quadrant
in 5 breasts dye was injected into upper lateral glandular tissue before breast reduction
|
After injection of dye, its distribution along lymphatic clearance paths was investigated
|
injection into medial upper quadrant
in 2 breasts dye was injected into upper medial glandular tissue before breast reduction
|
After injection of dye, its distribution along lymphatic clearance paths was investigated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymphatic flow is guided by the ligamentous suspension
Time Frame: The ligamentous suspension (horizontal septum, vertical ligaments merging into superficial fascia) is exposed in the course of breast reduction in the technique, that I described usually within about 40 minutes
|
colour gathered along horizontal septum
|
The ligamentous suspension (horizontal septum, vertical ligaments merging into superficial fascia) is exposed in the course of breast reduction in the technique, that I described usually within about 40 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elisabeth Würinger, Dr. Elisabeth Würinger
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)
May 25, 2021
Primary Completion (Actual)
July 10, 2021
Study Completion (Actual)
August 10, 2021
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
September 21, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 21, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- EK 21-102-VK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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