- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06678776
Endoscopic Anatomy of the Breast Fascia System
November 6, 2024 updated by: Haiyan Li
Endoscopic Anatomy of the Breast Fascia System: A Reverse Development Theory
This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory.
The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions.
However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed.
Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.
The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.
Study Overview
Study Type
Observational
Enrollment (Estimated)
184
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haiyan Li, Doctor
- Phone Number: +86 15813340604
- Email: lihy27@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Haiyan Li, Doctor
- Phone Number: +86 15813340604
- Email: lihy27@mail.sysu.edu.cn
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Inpatients of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.
Description
Inclusion Criteria:
- Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.
Exclusion Criteria:
- breast conserving surgery
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 |
|---|---|
|
Endoscopic Surgery
patients who underwent endoscopic breast surgery
|
Explore the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty.
|
|
Reduction Mammaplasty
patients who underwent reduction mammaplasty
|
Explore the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of ligaments
Time Frame: 1 year
|
The identification of ligaments primarily relies on the observation of membranous structures, and record the number of cases.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 1, 2019
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
October 27, 2024
First Submitted That Met QC Criteria
November 6, 2024
First Posted (Estimated)
November 7, 2024
Study Record Updates
Last Update Posted (Estimated)
November 7, 2024
Last Update Submitted That Met QC Criteria
November 6, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024ZSLYEC-560
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The corresponding database has not been established yet.
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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