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OpenTrials
Completed

NCT Number: NCT05560633

Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

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.

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Key information

Conditions

Breast/Surgery Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Total flap failure rate

    Time frame: Through study completion， and average of 2.5 year

    The rate of ms-tram and diep flap were removed from the patients

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2022
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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