Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05945914
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Actual Duration (Days): 7
• Patients Per Site Per Month: 39.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Reconstruction	Procedure: Oncoplastic Entirely Robot-Assisted Approach (OPERA)

Study Design

• Study Type: Observational
• Actual Enrollment: 9 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
• Actual Study Start Date: Jun 30, 2023
• Actual Primary Completion Date: Jul 7, 2023
• Actual Study Completion Date: Jul 7, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Re-open [Post-operative 14 days]

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

2. Acute complication (< 30 days) [Post-operative 30 days]

3. Chronic complication (> 30 days) [One year after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan	33305

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jung-Ju Huang, Associate Professor, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05945914
• Other Study ID Numbers: 202300888B0
• First Posted: Jul 14, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 14, 2023