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CompletedNCT06415526Updated May 16, 2024

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

An observational study in Breast Cancer and Mastectomy; Lymphedema, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
14
Ages
20 Years to 80 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Breast Cancer
  • Mastectomy; Lymphedema

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03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 14 is below the median of 106 across 144 observational studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Patients with previous pelvis surgeries (except C-section)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • OPERA group

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

    Procedure: OPERA

Interventions

  • ProcedureOPERA

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

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What researchers measure

Primary outcomes

  1. ARS incision

    The length of incision on anterior rectus sheath

    Time frame: Intra-operative

  2. Robotic time

    The time it took to dissect pedicles with robotic arms

    Time frame: Intra-operative

  3. Flap size

    The weight of the flap harvested

    Time frame: Intra-operative

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, 33305, Taiwan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06415526
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Jung-Ju Huang (Associate Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
May 16, 2024
Start date
May 3, 2024
Primary completion
May 10, 2024
Completion
May 10, 2024
Last update
May 16, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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