Clinical trial NCT03340623: Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?
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 ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mammary Reconstruction
Keywords: DIEP
Venous coupler
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women having had a total mastectomy and a mammary reconstruction by the DIEP technique with or without venous coupler utilisation, treated within the CHU Brugmann hospital between 01/01/2017 and 01/09/2017.

Brief 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.

Detailed 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.

Eligibility criteria: 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:

/

Primary outcomes:
measure: Rate of venous thrombosis
timeFrame: Up to 1 week after mammary reconstruction surgery
measure: Surgery duration
timeFrame: At the date of mammary reconstruction surgery.
measure: Anastomosis duration
timeFrame: At the date of mammary reconstruction surgery.
Secondary outcomes:
measure: Age
timeFrame: At the date of mammary reconstruction surgery.
measure: Body mass index
timeFrame: At the date of mammary reconstruction surgery.
measure: Tabagism
timeFrame: At the date of mammary reconstruction surgery.
measure: Co-morbidity : diabetes
timeFrame: At the date of mammary reconstruction surgery.
measure: Co-morbidity : cardio-vascular disease
timeFrame: At the date of mammary reconstruction surgery.
measure: Co-morbidity : medical history of venous thrombosis
timeFrame: At the date of mammary reconstruction surgery.
measure: Immediate of differed reconstruction
timeFrame: At the date of mammary reconstruction surgery.
measure: Unilateral or Bilateral DIEP
timeFrame: At the date of mammary reconstruction surgery.
measure: Medical complications (yes/no)
timeFrame: Up to one week after mammary reconstruction surgery
measure: Type of cancer treatment
timeFrame: At the date of mammary reconstruction surgery.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Claudia Miszewska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.