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

Sponsor
Chinese Academy of Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00514748
Collaborator
(none)
1
Location
2
Arms
28
Duration (Months)

Study Details

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 Phase
  • Procedure: DIEP
  • Procedure: Interconnected DIEP
 N/A

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
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
May 1, 2009

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. [more than one year after srugery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00514748
Other Study ID Numbers:
  • 621125-2
First Posted:
Aug 10, 2007
Last Update Posted:
Jun 24, 2009
Last Verified:
Jun 1, 2009
Keywords provided by , ,
breast reconstruction
DIEP
vessel pedicle
Additional relevant MeSH terms:
Diclofenac hydroxyethylpyrrolidine

Study Results

No Results Posted as of Jun 24, 2009