Successful Microsurgical Breast Reconstruction in Minimal... | NCT05943873

Studies
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy

NCT05943873

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Breast Reconstruction
Breast Cancer

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2023Actual

Primary Completion Date

Jul 5, 2023Actual

Completion Date

Jul 5, 2023Actual

First Submitted Date

Jul 4, 2023

First Submission Date that Met QC Criteria

Jul 4, 2023

First Posted Date

Jul 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2023

Last Update Posted Date

Jul 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Conventional mastectomy
Minimally invasive		robotic-assisted or endoscopic assisted mastectomies

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful	If the free flap transferred is successfully survived	post-operative 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
ChangGungMH		Taoyuan		33305	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38000051	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases