Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?

Mammary Reconstruction Clinical Trial

Official title:

Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340623
• Other study ID #: CHUB-venous coupler
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: May 28, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective study performed on medical records, in order to compare the number of venous thromboses, the surgery duration, the complications rate and the duration of anastomosis in breast reconstructive surgeries by the DIEP (Deep Inferior Epigastric Perforator Flap) technique, with or without the use of a venous coupler.

Description:

Breast cancer is the most common and deadliest cancer among women in Belgium. Women with invasive cancer may be offered a total mastectomy with or without adjuvant/neoadjuvant therapy, and with or without breast reconstruction. It is obvious that the loss of a breast can impact the self-image, hence the importance of informing the patient about the possibilities of breast reconstruction. Between 14 and 20% of women choose to resort to reconstruction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 28, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Total mastectomy with mammary reconstruction by the DIEP technique

• Patients treated within the CHU Brugmann Hospital

• Patients treated between 01/01/2017 and 01/09/2017

Exclusion Criteria:

Related Conditions & MeSH terms

• Mammary Reconstruction
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of venous thrombosis	Rate of venous thrombosis	Up to 1 week after mammary reconstruction surgery
Primary	Surgery duration	Duration of the mammary reconstruction surgery with the DIEP technique	At the date of mammary reconstruction surgery.
Primary	Anastomosis duration	Duration of the anastomosis during the mammary reconstruction surgery	At the date of mammary reconstruction surgery.
Secondary	Age	Patient age	At the date of mammary reconstruction surgery.
Secondary	Body mass index	Body mass index	At the date of mammary reconstruction surgery.
Secondary	Tabagism	Tabagism status (smoker/non smoker)	At the date of mammary reconstruction surgery.
Secondary	Co-morbidity : diabetes	Medical history of diabetes	At the date of mammary reconstruction surgery.
Secondary	Co-morbidity : cardio-vascular disease	Medical history of cardio-vascular disease	At the date of mammary reconstruction surgery.
Secondary	Co-morbidity : medical history of venous thrombosis	Medical history of venous thrombosis	At the date of mammary reconstruction surgery.
Secondary	Immediate of differed reconstruction	Reconstruction performed immediately after mastectomy or not	At the date of mammary reconstruction surgery.
Secondary	Unilateral or Bilateral DIEP	Unilateral or Bilateral DIEP	At the date of mammary reconstruction surgery.
Secondary	Medical complications (yes/no)	Medical complications within the grafted flap	Up to one week after mammary reconstruction surgery
Secondary	Type of cancer treatment	(neo)adjuvant chemiotherapy or (neo)adjuvant radiotherapy	At the date of mammary reconstruction surgery.

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