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

NCT ID: NCT00514748

Last Updated: 2009-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mammaplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients who receive breast reconstruction with bilateral DIEP flap based on bilateral vessel pedicles

Group Type ACTIVE_COMPARATOR

DIEP

Intervention Type PROCEDURE

flap survival, operation time, flap complications, donor site morbidity.

2

Patient who receive breast reconstruction with vessel interconnected DIEP flap based on one vessel pedicle

Group Type EXPERIMENTAL

Interconnected DIEP

Intervention Type PROCEDURE

flap survival, operation time, flap complications, donor site morbidity.

Interventions

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DIEP

flap survival, operation time, flap complications, donor site morbidity.

Intervention Type PROCEDURE

Interconnected DIEP

flap survival, operation time, flap complications, donor site morbidity.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Plastic Surgery Hospital of Chinese Academy of Medical Sciences

Principal Investigators

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Jie Luan, MD

Role: STUDY_CHAIR

Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science

Locations

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Plastic Surgery Hospital

Beijing, , China

Site Status

Countries

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China

References

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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):2337-2339. doi: 10.1097/01.prs.0000261064.22785.74. No abstract available.

Reference Type BACKGROUND
PMID: 17519766 (View on PubMed)

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):1385-1386. doi: 10.1097/01.prs.0000255180.17788.8c. No abstract available.

Reference Type BACKGROUND
PMID: 17496625 (View on PubMed)

Lasso JM, Sancho M, Campo V, Jimenez E, Perez Cano R. Epiperitoneal vessels: more resources to perform DIEP flaps. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):826-9. doi: 10.1016/j.bjps.2007.03.004. Epub 2007 Apr 18.

Reference Type BACKGROUND
PMID: 17446150 (View on PubMed)

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. doi: 10.1016/j.bjps.2006.11.008. Epub 2007 Jan 22.

Reference Type BACKGROUND
PMID: 17399662 (View on PubMed)

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. doi: 10.1016/j.bjps.2005.07.003. No abstract available.

Reference Type BACKGROUND
PMID: 16817262 (View on PubMed)

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. doi: 10.1097/01.prs.0000185867.84172.c0.

Reference Type BACKGROUND
PMID: 16404245 (View on PubMed)

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. doi: 10.1097/01.prs.0000110328.47206.50.

Reference Type BACKGROUND
PMID: 15083015 (View on PubMed)

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. doi: 10.1097/00006534-200302000-00087. No abstract available.

Reference Type BACKGROUND
PMID: 12560733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11370256 (View on PubMed)

Tran NV, Buchel EW, Convery PA. Microvascular complications of DIEP flaps. Plast Reconstr Surg. 2007 Apr 15;119(5):1397-1405. doi: 10.1097/01.prs.0000256045.71765.96.

Reference Type BACKGROUND
PMID: 17415232 (View on PubMed)

Blondeel PN. One hundred free DIEP flap breast reconstructions: a personal experience. Br J Plast Surg. 1999 Mar;52(2):104-11. doi: 10.1054/bjps.1998.3033.

Reference Type BACKGROUND
PMID: 10434888 (View on PubMed)

Other Identifiers

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621125-2

Identifier Type: -

Identifier Source: org_study_id

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