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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06321549
Other study ID # 202201562B0
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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