A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction

Study Overview
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Brief Summary
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Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in breast reconstruction.

Detailed Description
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The DIEP flap have become the most common and primary choice in autogenous tissue breast reconstruction nowadays. In cases with inadequate abdominal soft-tissue volume or abdominal midline scar, the bilateral DIEP flap is needed.However, it need two groups of recipient vessels. So it is unavailable in cases short of two groups of recipient vessels after radiotherapy. This study is aimed to solve the problems by interconnecting one of the branches of DIEA each side. The MDCT will be used to predict the branches and perforators of DIEA both sides. According to the branches of DIEAs, one branch will be anastomosed with that on contralateral side with only one vessel pedicle preserved on one side. We believe that the whole flap can be completely nourished with only one vessel pedicle by means of vessel interconnection.

Conditions
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Mammaplasty

Intervention / Treatment
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* Procedure: DIEP
* Procedure: Interconnected DIEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast lost after mastectomy With good general condition No pregnancy demand With additional soft tissue needed for reconstruction Exclusion Criteria: With bad general condition DIEA damaged by previous surgery Limited abdominal tissue

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients who receive breast reconstruction with bilateral DIEP flap based on bilateral vessel pedicles | Procedure: DIEP<br>* flap survival, operation time, flap complications, donor site morbidity.<br>|
| Experimental: 2<br>Patient who receive breast reconstruction with vessel interconnected DIEP flap based on one vessel pedicle | Procedure: Interconnected DIEP<br>* flap survival, operation time, flap complications, donor site morbidity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the whole flap may survived on the single vessel pedicle. |  | more than one year after srugery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIEP, breast reconstruction, vessel pedicle