Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?
NCT ID: NCT03340623
Last Updated: 2018-05-31
Study Results
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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COMPLETED
40 participants
OBSERVATIONAL
2017-11-01
2018-05-28
Brief Summary
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Detailed Description
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Different types of breast reconstruction exist: prosthetic reconstruction, lipolifting and flap reconstruction (of large dorsal, gluteus maximus, rectus abdominis muscle and "DIEP").
DIEP (Deep Inferior Epigastric Perforator Flap) presents numerous advantages. It consists in the use of a free cutaneo-greasy flap taken from the abdomen, without muscle removed. The abdominal skin has a similar appearance to the breast skin and, thanks to the presence of fat, the missing volume is replaced by a living tissue. Weakness of the abdominal wall is also avoided. However, it remains a surgical procedure with possible complications.
There are several steps in this surgery. The first is to dissect the abdominal flap by talking the skin and subcutaneous fat and isolating one or two branches of the lower epigastric artery and one or two veins. The donor area is then closed. The second step is to prepare the recipient area, ie dissect the artery that will be anastomosed with the lower deep epigastric artery.This artery can be the intern mammary artery, the thoraco-dorsal artery or more rarely the axillary artery. The third step consists of performing arterial and venous anastomoses and checking the quality of these.
Two microanastomoses must thus be performed: arterial and venous. The classic technique, the most used, is to suture the 2 veins. Alternatively, a coupler device can be used to perform the venous anastomosis.
It is therefore interesting to compare the classical method and the venous coupler method in terms of surgery duration, venous thrombosis and complications. If the coupler is proved effective, it could replace the manual suture.
Venous thrombosis is the main cause of flap failure. But surgery duration has also an impact on the complication rate, and the anastomosis duration corresponds to the time during which the flap is not perfused. It is thus necessary to keep it to a minimum in order to reduce the risk of flap loss.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Mammary reconstruction by DIEP with venous coupler
Venous coupler
A coupler can be used to perform a venous anastomosis. It is a double ring with pins on only one of its 2 faces. The technique consists in clamping the two veins, estimating the intima-to-intimal diameter of the vessels, choosing the coupler of the appropriate size, sliding the vein in the ring and evers the edges of the vessel to fix them on the pins, redo the same thing for the other vein and finally bring the two vessels together in order to clip them together.
Mammary reconstruction by DIEP without venous coupler
No interventions assigned to this group
Interventions
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Venous coupler
A coupler can be used to perform a venous anastomosis. It is a double ring with pins on only one of its 2 faces. The technique consists in clamping the two veins, estimating the intima-to-intimal diameter of the vessels, choosing the coupler of the appropriate size, sliding the vein in the ring and evers the edges of the vessel to fix them on the pins, redo the same thing for the other vein and finally bring the two vessels together in order to clip them together.
Eligibility Criteria
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Inclusion Criteria
* Patients treated within the CHU Brugmann Hospital
* Patients treated between 01/01/2017 and 01/09/2017
Exclusion Criteria
25 Years
75 Years
FEMALE
No
Sponsors
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Brugmann University Hospital
OTHER
Responsible Party
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Socorro ORTIZ
Head of clinic
Principal Investigators
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Claudia Miszewska, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann
Locations
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CHU Brugmann
Brussels, , Belgium
Countries
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References
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Camara O, Herrmann J, Egbe A, Koch I, Gajda M, Runnebaum IB. Venous coupler for free-flap anastomosis. Anticancer Res. 2009 Jul;29(7):2827-30.
Kulkarni AR, Mehrara BJ, Pusic AL, Cordeiro PG, Matros E, McCarthy CM, Disa JJ. Venous Thrombosis in Handsewn versus Coupled Venous Anastomoses in 857 Consecutive Breast Free Flaps. J Reconstr Microsurg. 2016 Mar;32(3):178-82. doi: 10.1055/s-0035-1563737. Epub 2015 Sep 15.
Rozen WM, Whitaker IS, Acosta R. Venous coupler for free-flap anastomosis: outcomes of 1,000 cases. Anticancer Res. 2010 Apr;30(4):1293-4.
Related Links
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Related Info
Other Identifiers
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CHUB-venous coupler
Identifier Type: -
Identifier Source: org_study_id