OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

NCT ID: NCT06415526

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-03

Study Completion Date

2024-05-10

Brief Summary

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Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.

Detailed Description

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Conditions

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Breast Cancer Mastectomy; Lymphedema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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OPERA group

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

OPERA

Intervention Type PROCEDURE

Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Interventions

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OPERA

Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with ASA (American Society of Anesthesiologist) classification 1-2
* Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
* The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple

Exclusion Criteria

* Patients with previous pelvis surgeries (except C-section)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Ju Huang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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Kuo WL, Wong AW, Tsai CY, Chen YF, Chang TN, Cheong DC, Huang JJ. Oncoplastic Entirely Robot-Assisted Approach: Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction. Plast Reconstr Surg. 2025 Oct 1;156(4):451e-460e. doi: 10.1097/PRS.0000000000012157. Epub 2025 Apr 21.

Reference Type DERIVED
PMID: 40261832 (View on PubMed)

Other Identifiers

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202400581B0

Identifier Type: -

Identifier Source: org_study_id

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