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.
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
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
Parallel
Nerve Suture
Procedure/SurgerySensory 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.
Semmes-Weinstein-Monofilament-Test
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).
Change in breast sensation
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.
Sensory recovery to DIEP flap
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast.
Change in breast sensation
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast. Measurement at the specified times (see time frame), determination of the delta.
Sensory recovery to DIEP flap
Vibration perception with tuning forks of 256 and 32 Hz. Binary: yes/no on 9 zones of the breast.
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Patricia Esther Engels
Lead sponsor
University Hospital, Geneva
Sponsor institution
