New Era of DIEP With Minimally Invasive Mastectomy

Completed

• Conditions: Breast Reconstruction; Mastectomy; Lymphedema
• Interventions: Other: The reference point of minimally invasive mastectomy procedure conducted

• Registration Number: NCT06321549
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-02
• Status Verified: 2024-03
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 278

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	The reference point of minimally invasive mastectomy procedure conducted	Individuals who underwent surgery after November 2018

Primary Outcome Measures

Name	Time	Method
Endoscopy mastectomy	Post-operative day 0
Usage of SIEV	Post-operative day 0
Inclusion of bipedicle	Post-operative day 0
Recipient artery/vein selection	Post-operative day 0
Robotic mastectomy	Post-operative day 0
Incision	Post-operative day 0
Location of recipient artery/vein	Post-operative day 0

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan