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Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05560633
Enrollment
147
Registered
2022-09-29
Start date
2015-05-01
Completion date
2020-12-31
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast/Surgery

Keywords

breast cancer, DIEP, ms-TRAM, breast reconstruction, learning curve, nipple spring mastectomy

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total flap failure rateThrough study completion, and average of 2.5 yearThe rate of ms-tram and diep flap were removed from the patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026