Mammary ReconstructionNCT03340623
Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?
An observational study of Mammary Reconstruction, run by Brugmann University Hospital at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Mammary Reconstruction
- What is being tested?
- Venous coupler
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 28 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mammary Reconstruction
- Being tested
- Venous coupler
- Keywords
- DIEP, Venous coupler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous couplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mammary reconstruction by DIEP with venous coupler | Not described Receives: Device: Venous coupler | |
| Mammary reconstruction by DIEP without venous coupler | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of venous thrombosis
Rate of venous thrombosis
Measured: Up to 1 week after mammary reconstruction surgery
Surgery duration
Duration of the mammary reconstruction surgery with the DIEP technique
Measured: At the date of mammary reconstruction surgery.
Anastomosis duration
Duration of the anastomosis during the mammary reconstruction surgery
Measured: At the date of mammary reconstruction surgery.
Secondary outcomes (10)
Age
Patient age
Measured: At the date of mammary reconstruction surgery.
Body mass index
Body mass index
Measured: At the date of mammary reconstruction surgery.
Tabagism
Tabagism status (smoker/non smoker)
Measured: At the date of mammary reconstruction surgery.
Co-morbidity : diabetes
Medical history of diabetes
Measured: At the date of mammary reconstruction surgery.
Co-morbidity : cardio-vascular disease
Medical history of cardio-vascular disease
Measured: At the date of mammary reconstruction surgery.
Co-morbidity : medical history of venous thrombosis
Medical history of venous thrombosis
Measured: At the date of mammary reconstruction surgery.
Immediate of differed reconstruction
Reconstruction performed immediately after mastectomy or not
Measured: At the date of mammary reconstruction surgery.
Unilateral or Bilateral DIEP
Unilateral or Bilateral DIEP
Measured: At the date of mammary reconstruction surgery.
Medical complications (yes/no)
Medical complications within the grafted flap
Measured: Up to one week after mammary reconstruction surgery
Type of cancer treatment
(neo)adjuvant chemiotherapy or (neo)adjuvant radiotherapy
Measured: At the date of mammary reconstruction surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Nov 2017
- Primary completion28 May 2018
- Study completion28 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mammary ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Socorro ORTIZ, Brugmann University Hospital
- Investigators
- Claudia Miszewska, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340623
- Sponsor's protocol ID
- CHUB-venous coupler
- Status last verified
- May 2018
- First submitted
- 9 Nov 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19596969Kulkarni 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.
PubMed 26372685Rozen WM, Whitaker IS, Acosta R. Venous coupler for free-flap anastomosis: outcomes of 1,000 cases. Anticancer Res. 2010 Apr;30(4):1293-4.
PubMed 20530442
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ?
- ClinicalTrials.gov ID
- NCT03340623
- Acronym / sponsor ID
- CHUB-venous coupler
- Conditions
- Mammary Reconstruction
- Keywords
- DIEP, Venous coupler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammary reconstruction by DIEP with venous coupler | – | Device: Venous coupler |
| Mammary reconstruction by DIEP without venous coupler | – | – |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous couplerA 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. | Device | Mammary reconstruction by DIEP with venous coupler |
Primary outcome
Rate of venous thrombosis
Time frame: Up to 1 week after mammary reconstruction surgery
Rate of venous thrombosis
Surgery duration
Time frame: At the date of mammary reconstruction surgery.
Duration of the mammary reconstruction surgery with the DIEP technique
Anastomosis duration
Time frame: At the date of mammary reconstruction surgery.
Duration of the anastomosis during the mammary reconstruction surgery
10 secondary outcomes
Age
Time frame: At the date of mammary reconstruction surgery.
Body mass index
Time frame: At the date of mammary reconstruction surgery.
Tabagism
Time frame: At the date of mammary reconstruction surgery.
Co-morbidity : diabetes
Time frame: At the date of mammary reconstruction surgery.
Co-morbidity : cardio-vascular disease
Time frame: At the date of mammary reconstruction surgery.
Co-morbidity : medical history of venous thrombosis
Time frame: At the date of mammary reconstruction surgery.
Immediate of differed reconstruction
Time frame: At the date of mammary reconstruction surgery.
Unilateral or Bilateral DIEP
Time frame: At the date of mammary reconstruction surgery.
Medical complications (yes/no)
Time frame: Up to one week after mammary reconstruction surgery
Type of cancer treatment
Time frame: At the date of mammary reconstruction surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Background: PubMed 19596969Camara 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.
- Background: PubMed 26372685Kulkarni 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.
- Background: PubMed 20530442Rozen 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Miszewska, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammary Reconstruction, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of venous thrombosis (time frame: Up to 1 week after mammary reconstruction surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340623, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.