NCT05560633

Brief Summary

  1. 1.Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
  2. 2.Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
  3. 3.The complication rates of the flap and oncological safety were studied.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

5.7 years

First QC Date

September 13, 2022

Last Update Submit

September 27, 2022

Conditions

Breast/Surgery

Keywords

breast cancerDIEPms-TRAMbreast reconstructionlearning curvenipple spring mastectomy

Outcome Measures

Primary Outcomes (1)

  • Total flap failure rate

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

    Through study completion， and average of 2.5 year

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The eligibility of patients for free-TRAM/DIEP was based on the judgement of surgeons, preference of patients, and guideline recommendation as a standard-of-care. For NSM, patients should receive standard-of-care physical examination, ultrasound, mammogram and/or MRI assessment of the involved breast. Patients with clinical involvement of the nipple areola complex (NAC) were excluded

You may qualify if:

  • Female breast cancer patients with age \> 18 years
  • Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)

You may not qualify if:

  • Breast conserving patient
  • Implant-based breast reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38355459DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 29, 2022

Study Start

May 1, 2015

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 29, 2022

Record last verified: 2022-09