NCT05897463

Brief Summary

A retrospective chart review will be conducted to identify patients receiving breast reconstruction and simultaneous breast neurotization. Their reconstructed breasts will be included as study group. Patients receiving breast reconstruction without neurotization will be included as negative control group. Their contralateral normal breasts in the study and the negative control group will be included as positive control. Patients' demographic data, their breast cancer treatment parameters, such as the staging, previous radiotherapy history, postmastectomy radiotherapy, neoadjuvant and adjuvant chemotherapy will be included. The reconstruction results will be evaluated as well. Statistics Data will be analyzed using graphing and statistical analysis software. Independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant. Potential risks: No Confidentiality: All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2023

Last Update Submit

June 7, 2023

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively

    post-operative 6, 12, 18, 24, and 30 months

Study Arms (2)

Neurotized

Non-neurotized

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.

You may qualify if:

  • patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.
  • patients who received breast reconstruction without neurotization were included as the non-neurotized group.

You may not qualify if:

  • patients unable to complete the follow-up were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangGungMH

Taoyuan District, 33305, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 9, 2023

Study Start

September 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

TW(1)