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

June 23, 2009 updated by: Chinese Academy of Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100041
        • Plastic Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Patients who receive breast reconstruction with bilateral DIEP flap based on bilateral vessel pedicles
Procedure: DIEP
flap survival, operation time, flap complications, donor site morbidity.
EXPERIMENTAL: 2
Patient who receive breast reconstruction with vessel interconnected DIEP flap based on one vessel pedicle
Procedure: Interconnected DIEP
flap survival, operation time, flap complications, donor site morbidity.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Investigators

  • Study Chair: Jie Luan, MD, Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (ESTIMATE)

August 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2009

Last Update Submitted That Met QC Criteria

June 23, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 621125-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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