NCT07419971

Brief Summary

The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

February 12, 2026

Last Update Submit

March 15, 2026

Conditions

Breast Cancer FemalesBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Aesthetic Outcome

    Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).

    From enrollment to the end of follow up at 6 months

Study Arms (2)

Mesh

implant- based breast reconstruction with synthetic mesh

Procedure: synthetic mesh

Without Mesh

implant- based breast reconstruction without synthetic mesh

Interventions

synthetic meshPROCEDURE

Whether synthetic meshes are used in breast cancer patients for immediate breast reconstruction after breast cancer resection

Mesh

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients who undergoing mastectomy and the implant- based breast reconstruction for breast cancer or prophylactic reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

March 1, 2026

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)