New Era of DIEP With Minimally Invasive Mastectomy

Breast Reconstruction Clinical Trial

Official title:

Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06321549
• Other study ID #: 202201562B0
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: October 2, 2023

Study information

• Verified date: March 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques. Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
• Patients who have a minimum follow-up duration of six months post-reconstruction.

Exclusion Criteria:

• Patients who did not meet the six-month follow-up duration was excluded from the study.

Related Conditions & MeSH terms

• Breast Reconstruction
• Lymphedema
• Mastectomy; Lymphedema

Intervention

Other:
• The reference point of minimally invasive mastectomy procedure conducted
November 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopy mastectomy		Post-operative day 0
Primary	Robotic mastectomy		Post-operative day 0
Primary	Incision		Post-operative day 0
Primary	Usage of SIEV		Post-operative day 0
Primary	Inclusion of bipedicle		Post-operative day 0
Primary	Location of recipient artery/vein		Post-operative day 0
Primary	Recipient artery/vein selection		Post-operative day 0