Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

Completed

• Conditions: Breast/Surgery

• Registration Number: NCT05560633
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 Timeline

• Study Start: 2015-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 147

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total flap failure rate	Through study completion， and average of 2.5 year	The rate of ms-tram and diep flap were removed from the patients