Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

Breast/Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560633
• Other study ID #: SYSEC-KY-KS-2021-144
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female breast cancer patients with age > 18 years

• Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)

Exclusion Criteria:

• Breast conserving patient

• Implant-based breast reconstruction

Related Conditions & MeSH terms

• Breast/Surgery

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total flap failure rate	The rate of ms-tram and diep flap were removed from the patients	Through study completion, and average of 2.5 year