NCT00514748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

1.6 years

First QC Date

August 9, 2007

Last Update Submit

June 23, 2009

Conditions

Mammaplasty

Keywords

breast reconstructionDIEPvessel pedicle

Outcome Measures

Primary Outcomes (1)

  • the whole flap may survived on the single vessel pedicle.

    more than one year after srugery

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: DIEP

2

EXPERIMENTAL

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

Procedure: Interconnected DIEP

Interventions

DIEPPROCEDURE

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

1
Interconnected DIEPPROCEDURE

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast lost after mastectomy
  • With good general condition
  • No pregnancy demand
  • With additional soft tissue needed for reconstruction

You may not qualify if:

  • With bad general condition
  • DIEA damaged by previous surgery
  • Limited abdominal tissue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plastic Surgery Hospital

Beijing, 100041, China

Location

Related Publications (11)

  • 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.

    PMID: 17519766BACKGROUND

  • 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.

    PMID: 17496625BACKGROUND

  • 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.

    PMID: 17446150BACKGROUND

  • 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.

    PMID: 17399662BACKGROUND

  • 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.

    PMID: 16817262BACKGROUND

  • 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.

    PMID: 16404245BACKGROUND

  • 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.

    PMID: 15083015BACKGROUND

  • 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.

    PMID: 12560733BACKGROUND

  • 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.

    PMID: 11370256BACKGROUND

  • 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.

    PMID: 17415232BACKGROUND

  • 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.

    PMID: 10434888BACKGROUND

MeSH Terms

Interventions

diclofenac hydroxyethylpyrrolidine

Study Officials

  • Jie Luan, MD

    Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

May 1, 2009

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

CN(1)