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

This study has been completed.
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00514748
First received: August 9, 2007
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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 Intervention
Mammaplasty
Procedure: DIEP
Procedure: Interconnected DIEP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • the whole flap may survived on the single vessel pedicle. [ Time Frame: more than one year after srugery ] [ Designated as safety issue: Yes ]

Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 9, 2007
Last Updated: June 23, 2009
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Diclofenac hydroxyethylpyrrolidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014