Breast Cancer Surgery, DIEP Flap Breast Reconstruction, Reconstruction Breast Surgery, Sensitization
Conditions
Keywords
free flap, breast reconstruction, autologous-based reconstruction, neurotization, sensory recovery, post-mastectomy sensation, autologous breast reconstruction, DIEP flap
Brief summary
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. The main question is: If a nerve suture was carried out, can pressure be felt better on the reconstructed breast after 12 months? If a nerve suture was carried out, will better sensibility and quality of life be felt and perceived (questionnaire) at 12 and 24 months after the initial operation ? Researchers will compare two different nerve suture techniques and no nerve suture to one another to see if and which nerve suture optimizes sensibility. Participants will have regular visits and follow-up controls, during which * their sensibility will be tested multimodally, * they will fill out questionnaires * skin biopsies will be taken.
Detailed description
Breast reconstruction with autologous tissue is one of the most important methods: The DIEP (deep inferior epigastric artery perforator) flap is today's workhorse in autologous reconstruction. Routinely, the arteries and veins of the donor- and recipient sites are connected, but not the nerves. The sensory recovery is an undervalued aspect despite the disadvantages of insensate flaps. Connection of the abdominal flap skin's nerves to the breast region's nerves allows sensitized reconstruction. The research project aims to make sensitized flap-based breast reconstruction the standard method by proving its superiority, using the sensory testing with Semmes-Weinstein-Monofilament (pressure threshold) as the primary outcome measured before surgery and 12 months post-surgery. Therefore, patients will be randomized in three groups: 1. sensitization with direct nerve suture or 2. autograft or 3. no sensitization. Moreover, no previous studies have analyzed the potential changes in flap skin with proteomics, thus justifying our secondary objective. The hypothesis is that flaps with nerve suture(s) have better sensibility. The main outcome will be the sensory testing (pressure threshold). As secondary outcomes the questionnaire will show the patients' quality of life, and the proteomic analysis, should, according to our hypothesis, show that quantity and expression of the proteins of flap skin with nerve suture are closer to normal skin than without nerve suture.
Interventions
PROCEDURENerve Suture
Sensory nerve coaptations will be performed 1. either by suturing the donor to the recipient nerve immediately (1 coaptation) 2. or by interposing an autograft originating from the zone of the flap to be discarded (2 coaptations). The anterior cutaneous branch (ACB) of the 3rd or 4th intercostal nerve (ICN) will be connected to the sensory branch of the 10th, 11th or 12th ICN of the flap.
Sponsors
Patricia Esther Engels
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Three-arm, Randomised, Double-blinded Superiority Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
A) Pilot study Inclusion criteria: * 18-80 years old * having received DIEP flap breast reconstruction with a flap not completely buried * having given written informed consent for participating in the study
Exclusion criteria
* postoperative radiotherapy on the flap * neurological conditions as diabetic neuropathy, alcoholism or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications * active smoking * language barrier * pregnancy or lactating women B) Main study Inclusion Criteria: * 18 to 80 years old * having given written informed consent for participating in the study * receiving immediate or delayed unilateral DIEP breast reconstruction with a DIEP flap which will not be completely buried
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semmes-Weinstein-Monofilament-Test | At 12-months-follow-up | The results of one modality of the sensory testing, the Semmes-Weinstein-Monofilament-Test for pressure perception. The breast will be divided into 9 zones, which will all be measured with the Semmes Weinstein monofilament 20-piece full kit (unit: grams of force) at the given time (see time frame). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory recovery to DIEP flap | 12 months postop | 2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast. |
| Breast-specific health-related QoL | 12 months postop | Breast-Q® |
| Change in breast sensation | day-1/1week/3/6/12/24 months postop | Semmes-Weinstein monoflament The breast will be divided into 9 zones, which will all be measured with the Semmes Weinstein monofilament 20-piece full kit at the given times (see time frame). The resulting monofilament values (unit: grams of force) are examined over the various specified periods and the delta is determined. |
| Operative time | At time of 1st operation | Minutes for nerve coaptation(s) |
| Changes to DIEP flap skin | A) Pilot study Postoperatively at any time of follow-up-interventions. B) Main study At time of 1st operation and at 6-months-follow-up | Proteomics, neuroprotein quantification |
| Breast-specific health-related QoL (change over time) | Day -1, 12 &24 months postop | Breast-Q®, delta of points over time (see time frame) |
Countries
Switzerland
Contacts
Primary ContactPatricia E Engels, MD
Backup ContactAxelle Serre, MD
Outcome results
None listed