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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mammary Reconstruction

Intervention / Treatment
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* Device: Venous coupler


Participation Criteria
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Eligibility Criteria
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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: /

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mammary reconstruction by DIEP with venous coupler<br> | Device: Venous coupler<br>* 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.<br>|
| Mammary reconstruction by DIEP without venous coupler<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of venous thrombosis | Rate of venous thrombosis | Up to 1 week after mammary reconstruction surgery | 
| Surgery duration | Duration of the mammary reconstruction surgery with the DIEP technique | At the date of mammary reconstruction surgery. | 
| Anastomosis duration | Duration of the anastomosis during the mammary reconstruction surgery | At the date of mammary reconstruction surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Patient age | At the date of mammary reconstruction surgery. | 
| Body mass index | Body mass index | At the date of mammary reconstruction surgery. | 
| Tabagism | Tabagism status (smoker/non smoker) | At the date of mammary reconstruction surgery. | 
| Co-morbidity : diabetes | Medical history of diabetes | At the date of mammary reconstruction surgery. | 
| Co-morbidity : cardio-vascular disease | Medical history of cardio-vascular disease | At the date of mammary reconstruction surgery. | 
| Co-morbidity : medical history of venous thrombosis | Medical history of venous thrombosis | At the date of mammary reconstruction surgery. | 
| Immediate of differed reconstruction | Reconstruction performed immediately after mastectomy or not | At the date of mammary reconstruction surgery. | 
| Unilateral or Bilateral DIEP | Unilateral or Bilateral DIEP | At the date of mammary reconstruction surgery. | 
| Medical complications (yes/no) | Medical complications within the grafted flap | Up to one week after mammary reconstruction surgery | 
| Type of cancer treatment | (neo)adjuvant chemiotherapy or (neo)adjuvant radiotherapy | At the date of mammary reconstruction surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIEP, Venous coupler