Viewing Study NCT05560633


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Study NCT ID: NCT05560633
Status: COMPLETED
Last Update Posted: 2022-09-29
First Post: 2022-09-13
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:

Study Overview

Official Title: The Feasibility of Nipple-sparing Mastectomy in Combined With Abdominal Free Flap Breast Reconstruction Without Skin Paddles for Flap Monitoring: a Single-center Experience
Status: COMPLETED
Status Verified Date: 2022-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
3. The complication rates of the flap and oncological safety were studied.
Detailed Description: Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.

Buried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.

Complication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: