A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction - Full Text View

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:

MedlinePlus related topics: Breast Reconstruction Plastic and Cosmetic Surgery

U.S. FDA Resources

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

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:

Bains RD, Stanley PR, Riaz M. Avoiding donor-site complications with bilateral DIEP flaps in patients with subcostal scars. Plast Reconstr Surg. 2007 Jun;119(7):2337-9. No abstract available.

Bains RD, Riaz M, Stanley P. Bilateral free DIEP breast reconstruction using contralateral internal mammary and ipsilateral thoracodorsal vessels. Plast Reconstr Surg. 2007 Apr 1;119(4):1385-6. No abstract available.

Lasso JM, Sancho M, Campo V, Jimenez E, Perez Cano R. Epiperitoneal vessels: more resources to perform DIEP flaps. J Plast Reconstr Aesthet Surg. 2007 Apr 17; [Epub ahead of print]

Schoeller T, Wechselberger G, Roger J, Hussl H, Huemer GM. Management of infraumbilical vertical scars in DIEP-flaps by crossover anastomosis. J Plast Reconstr Aesthet Surg. 2007;60(5):524-8. Epub 2007 Jan 22.

Das-Gupta R, Busic V, Begic A. Deep inferior epigastric perforator flap (DIEP) breast reconstruction in the presence of a midline vertical scar. J Plast Reconstr Aesthet Surg. 2006;59(6):675-6. No abstract available.

Holm C, Mayr M, Hofter E, Ninkovic M. Perfusion zones of the DIEP flap revisited: a clinical study. Plast Reconstr Surg. 2006 Jan;117(1):37-43.

Gill PS, Hunt JP, Guerra AB, Dellacroce FJ, Sullivan SK, Boraski J, Metzinger SE, Dupin CL, Allen RJ. A 10-year retrospective review of 758 DIEP flaps for breast reconstruction. Plast Reconstr Surg. 2004 Apr 1;113(4):1153-60.

Garcia-Tutor E, Murillo J. The ideal patient for the first breast reconstruction using a diep flap. Plast Reconstr Surg. 2003 Feb;111(2):947-8. No abstract available.

Vesely J, Stupka I, Drazan L, Holusa P, Licata P, Corradini B. DIEP flap breast reconstruction--new experience. Acta Chir Plast. 2001;43(1):3-6.

Tran NV, Buchel EW, Convery PA. Microvascular complications of DIEP flaps. Plast Reconstr Surg. 2007 Apr 15;119(5):1397-405; discussion 1406-8.

Blondeel PN. One hundred free DIEP flap breast reconstructions: a personal experience. Br J Plast Surg. 1999 Mar;52(2):104-11.

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 May 23, 2013