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

Mammaplasty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514748
• Other study ID #: 621125-2
• Status: Completed
• Phase: N/A
• First received: August 9, 2007
• Last updated: June 23, 2009
• Start date: January 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Mammaplasty

Intervention

Procedure:
• DIEP
flap survival, operation time, flap complications, donor site morbidity.
• Interconnected DIEP
flap survival, operation time, flap complications, donor site morbidity.

Locations

Country	Name	City	State
China	Plastic Surgery Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

Lasso JM, Sancho M, Campo V, Jiménez E, Pérez Cano R. Epiperitoneal vessels: more resources to perform DIEP flaps. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):826-9. Epub 2007 Apr 18. — View Citation

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. — View Citation

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

Veselý 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the whole flap may survived on the single vessel pedicle.		more than one year after srugery	Yes