NCT05943873

Brief Summary

A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

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

June 30, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

5 days

First QC Date

July 4, 2023

Last Update Submit

July 4, 2023

Conditions

Breast ReconstructionBreast Cancer

Keywords

free flapbreast reconstructionminimally invasive mastectomynipple-sparing mastectomyrobotic-assisted mastectomyendoscopic-assisted mastectomy

Outcome Measures

Primary Outcomes (1)

  • Successful

    If the free flap transferred is successfully survived

    post-operative 7 days

Study Arms (2)

Control

Conventional mastectomy

Minimally invasive

robotic-assisted or endoscopic assisted mastectomies

Eligibility Criteria

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

patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon

You may qualify if:

  • patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.

You may not qualify if:

  • patients failed to be examined for outcome evaluation will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangGungMH

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

  • Wong AW, Kuo WL, Cheong DC, Tsai HP, Kao SW, Chen CF, Huang JJ. Six steps for a successful aesthetic free flap reconstruction after minimally invasive mastectomy: a retrospective case-control study. Int J Surg. 2024 Feb 1;110(2):645-653. doi: 10.1097/JS9.0000000000000871.

    PMID: 38000051DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 13, 2023

Study Start

June 30, 2023

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

TW(1)