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

• ClinicalTrials.gov Identifier: NCT03340623
• Recruitment Status: Completed
• First Posted: November 13, 2017
• Last Update Posted: May 31, 2018
• Sponsor: Brugmann University Hospital
• Information provided by (Responsible Party): Socorro ORTIZ, Brugmann University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Mammary Reconstruction	Device: 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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 ?
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: May 28, 2018
• Actual Study Completion Date: May 28, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Mammary reconstruction by DIEP with venous coupler	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.
Mammary reconstruction by DIEP without venous coupler

Outcome Measures

Primary Outcome Measures :

1. Rate of venous thrombosis [ Time Frame: Up to 1 week after mammary reconstruction surgery ]
   Rate of venous thrombosis
2. Surgery duration [ Time Frame: At the date of mammary reconstruction surgery. ]
   Duration of the mammary reconstruction surgery with the DIEP technique
3. Anastomosis duration [ Time Frame: At the date of mammary reconstruction surgery. ]
   Duration of the anastomosis during the mammary reconstruction surgery

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

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:

/

Contacts and Locations

Locations

Belgium

CHU Brugmann

Brussels, Belgium, 1020

Sponsors and Collaborators

Brugmann University Hospital

Investigators

• Principal Investigator: Claudia Miszewska, MD; CHU Brugmann

More Information

Additional Information:

Related Info 

Related Info 

Publications:

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.

• Responsible Party: Socorro ORTIZ, Head of clinic, Brugmann University Hospital
• ClinicalTrials.gov Identifier: NCT03340623
• Other Study ID Numbers: CHUB-venous coupler
• First Posted: November 13, 2017
• Last Update Posted: May 31, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Socorro ORTIZ, Brugmann University Hospital:

DIEP; Venous coupler

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases