An interventional study of Nerve Suture in Breast Cancer Surgery, Reconstruction Breast Surgery and Sensitization, sponsored by Patricia Esther Engels. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Patricia Esther Engels · Not applicable, Interventional, and Treatment
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
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:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 63 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Patricia Esther Engels as lead sponsor.
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A) Pilot study
Inclusion criteria:
Exclusion criteria:
B) Main study
Inclusion Criteria:
Exclusion Criteria:
No nerve suture will be carried out.
Epineural coaptation of one nerve of the flap to one nerve of the breast region
Procedure: Nerve Suture
Epineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft
Procedure: Nerve 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.
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).
Time frame: At 12-months-follow-up
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.
Time frame: day-1/1week/3/6/12/24 months postop
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.
Time frame: 12 months postop
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.
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Vibration perception with tuning forks of 256 and 32 Hz. Binary: yes/no on 9 zones of the breast.
Time frame: 12 months postop
Change in breast sensation
Vibration perception with tuning forks of 256 and 32 Hz. 9 zones of the breast. Binary: yes/no Evaluation of the difference in the number of zones of the breast with perception of vibration, delta over different time points.
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Temperature perception. Metal rods of 6°C and 37°C. Patients have to indicate which rod feels colder that the other. Capacity of differentiation of temperature: yes/no on 9 zones of the breast.
Time frame: 12 months postop
Change in breast sensation
Temperature perception. Metal rods of 6°C and 37°C. Patients have to indicate which rod feels colder that the other. Capacity of differentiation of temperature: yes/no on 9 zones of the breast. Testing at given time points (see time frame), Calculation of delta of number of zones with distinction.
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Temperature surface. FLIR thermal camera, flap monitor versus whole breast and contralateral breast surface temperature, difference in temperature in degree Celsius.
Time frame: 12 months postop
Change in breast sensation
Temperature surface. FLIR thermal camera, flap monitor versus whole breast and contralateral breast surface temperature, difference in temperature in degree Celsius. Calculation of delta over given time points (see time frame)
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Sharp/dull: Instrument system used: 18G needle / cotton swab, on nine areas of the breast. * Each area will be tested 3 consecutive times with both objects (i.e., 6 measurements per area) * The distinction between prick and gentle pressure will be considered successful if the patient responds correctly 5 times out of 6 or 6 times out of 6 (distinction ability: yes/no)
Time frame: 12 months postop
Change in breast sensation
Sharp/dull: Instrument system used: 18G needle / cotton swab, on nine areas of the breast. * Each area will be tested 3 consecutive times with both objects (i.e., 6 measurements per area) * The distinction between prick and gentle pressure will be considered successful if the patient responds correctly 5 times out of 6 or 6 times out of 6 (distinction ability: yes/no) Delta calculation over given time points (see time frame)
Time frame: day-1/1week/3/6/12/24 months postop
Breast-specific health-related QoL
Breast-Q®
Time frame: 12 months postop
Breast-specific health-related QoL (change over time)
Breast-Q®, delta of points over time (see time frame)
Time frame: Day -1, 12 &24 months postop
Operative time
Minutes for nerve coaptation(s)
Time frame: At time of 1st operation
Changes to DIEP flap skin
Proteomics, neuroprotein quantification
Time frame: 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
Sensory recovery to DIEP flap
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer.
Time frame: 12 months postop
Plan to share: No
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