NCT06678776

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

5.6 years

First QC Date

October 27, 2024

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of ligaments

    The identification of ligaments primarily relies on the observation of membranous structures, and record the number of cases.

    1 year

Study Arms (2)

Endoscopic Surgery

patients who underwent endoscopic breast surgery

Procedure: surgery

Reduction Mammaplasty

patients who underwent reduction mammaplasty

Procedure: surgery

Interventions

surgeryPROCEDURE

Explore the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty.

Endoscopic SurgeryReduction Mammaplasty

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

  • Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.

You may not qualify if:

  • breast conserving surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Breast Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 27, 2024

First Posted

November 7, 2024

Study Start

June 1, 2019

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations