Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05943873
Collaborator
(none)
63
1
5
383.5
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
63 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy
Actual Study Start Date
:
Jun 30, 2023
Actual Primary Completion Date
:
Jul 5, 2023
Actual Study Completion Date
:
Jul 5, 2023
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Control Conventional mastectomy |
|
Minimally invasive robotic-assisted or endoscopic assisted mastectomies |
Outcome Measures
Primary Outcome Measures
- Successful [post-operative 7 days]
If the free flap transferred is successfully survived
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ChangGungMH | Taoyuan | Taiwan | 33305 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jung-Ju Huang,
Associate Professor,
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05943873
Other Study ID Numbers:
- 202300895B0
First Posted:
Jul 13, 2023
Last Update Posted:
Jul 13, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jung-Ju Huang,
Associate Professor,
Chang Gung Memorial Hospital