Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

NCT ID: NCT05560633

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Breast/Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Li S, Zhang S, Zhang X, Yan J, Wang S, Tan L, Rao N, Chen K, Zhu L. The learning curve of the MS-TRAM/DIEP breast reconstruction by dual-trained breast surgeons. BMC Surg. 2024 Feb 14;24(1):53. doi: 10.1186/s12893-024-02344-z.

Reference Type DERIVED
PMID: 38355459 (View on PubMed)

Other Identifiers

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SYSEC-KY-KS-2021-144

Identifier Type: -

Identifier Source: org_study_id

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