Clincosm LogoSign in Get a demo

Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Completed
CT.gov ID
NCT05560633
Collaborator
(none)
147
Enrollment
68
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Actual Enrollment :
147 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05560633
Other Study ID Numbers:
  • SYSEC-KY-KS-2021-144
First Posted:
Sep 29, 2022
Last Update Posted:
Sep 29, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
breast cancer
DIEP
ms-TRAM
breast reconstruction
learning curve
nipple spring mastectomy

Study Results

No Results Posted as of Sep 29, 2022