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

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ClinicalTrials.gov Identifier: NCT00514748
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Mammaplasty Procedure: DIEP Procedure: Interconnected DIEP

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 Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2007
Primary Completion Date : August 2008
Study Completion Date : May 2009

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U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. the whole flap may survived on the single vessel pedicle. [ Time Frame: more than one year after srugery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514748


Locations
China
Plastic Surgery Hospital
Beijing, China, 100041
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
Study Chair: Jie Luan, MD Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science
More Information

Publications:

Responsible Party: Yilin Cao, Plastic Surgery Hospital of Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00514748     History of Changes
Other Study ID Numbers: 621125-2
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by Chinese Academy of Sciences:
breast reconstruction
DIEP
vessel pedicle

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Diclofenac hydroxyethylpyrrolidine
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents