NCT05945914

Brief Summary

A prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free DIEP flap harvest for breast reconstruction between March 2020 and June 25, 2023. Demographic data, including age, body mass index (BMI), and medical history, were collected, along with surgical time and perioperative parameters. The incidence of acute and chronic complications was documented.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

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

June 30, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

7 days

First QC Date

July 7, 2023

Last Update Submit

July 7, 2023

Conditions

Breast CancerBreast Reconstruction

Outcome Measures

Primary Outcomes (3)

  • Re-open

    Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.

    Post-operative 14 days

  • Acute complication (< 30 days)

    Post-operative 30 days

  • Chronic complication (> 30 days)

    One year after surgery

Study Arms (1)

Study group

Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction.

Procedure: Oncoplastic Entirely Robot-Assisted Approach (OPERA)

Interventions

Oncoplastic Entirely Robot-Assisted Approach (OPERA)PROCEDURE

Robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

Study group

Eligibility Criteria

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

Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

You may qualify if:

  • Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 14, 2023

Study Start

June 30, 2023

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

TW(1)