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| ID | Type | Description | Link |
|---|---|---|---|
| BASEC2024-02109 | Other Identifier | BASEC (Business Administration System for Ethics Committees) Switzerland |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no nerve suture | No Intervention | No nerve suture will be carried out. | |
| direct nerve suture | Experimental | Epineural coaptation of one nerve of the flap to one nerve of the breast region |
|
| interposition of an autograft | Experimental | Epineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Suture | Procedure | Sensory nerve coaptations will be performed
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 12-months-follow-up |
| Measure | Description | 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. | day-1/1week/3/6/12/24 months postop |
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A) Pilot study
Inclusion criteria:
Exclusion criteria:
B) Main study
Inclusion Criteria:
Exclusion Criteria:
XX chromosome patients willing to have autologous breast reconstruction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia E Engels, MD | Contact | +41795537557 | patricia.engels@hug.ch | |
| Axelle Serre, MD | Contact | +41795538642 | axelle.serre@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Patricia E Engels, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Canton of Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28673764 | Background | Puonti HK, Broth TA, Soinila SO, Hallikainen HK, Jaaskelainen SK. How to Assess Sensory Recovery After Breast Reconstruction Surgery? Clin Breast Cancer. 2017 Oct;17(6):471-485. doi: 10.1016/j.clbc.2017.04.011. Epub 2017 Apr 29. | |
| 10343589 | Background | Blondeel PN, Demuynck M, Mete D, Monstrey SJ, Van Landuyt K, Matton G, Vanderstraeten GG. Sensory nerve repair in perforator flaps for autologous breast reconstruction: sensational or senseless? Br J Plast Surg. 1999 Jan;52(1):37-44. doi: 10.1054/bjps.1998.3011. |
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Three-arm, Randomised, Double-blinded Superiority Trial
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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.
| 12 months postop |
| Change in breast sensation | Sharp/dull: Instrument system used: 18G needle / cotton swab, on nine areas of the breast.
| day-1/1week/3/6/12/24 months postop |
| Breast-specific health-related QoL | Breast-Q® | 12 months postop |
| Breast-specific health-related QoL (change over time) | Breast-Q®, delta of points over time (see time frame) | Day -1, 12 &24 months postop |
| Operative time | Minutes for nerve coaptation(s) | At time of 1st operation |
| Changes to DIEP flap skin | Proteomics, neuroprotein quantification | 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. | 12 months postop |
| 19116520 | Background | Spiegel AJ, Salazar-Reyes H, Izaddoost S, Khan FN. A novel method for neurotization of deep inferior epigastric perforator and superficial inferior epigastric artery flaps. Plast Reconstr Surg. 2009 Jan;123(1):29e-30e. doi: 10.1097/PRS.0b013e3181905564. No abstract available. |
| 35993852 | Background | Bijkerk E, Beugels J, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Clinical Relevance of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction Evaluated Using the BREAST-Q. Plast Reconstr Surg. 2022 Nov 1;150(5):959e-969e. doi: 10.1097/PRS.0000000000009617. Epub 2022 Aug 22. |
| 35872020 | Background | Shiah E, Laikhter E, Comer CD, Manstein SM, Bustos VP, Bain PA, Lee BT, Lin SJ. Neurotization in Innervated Breast Reconstruction: A Systematic Review of Techniques and Outcomes. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2890-2913. doi: 10.1016/j.bjps.2022.06.006. Epub 2022 Jun 17. |
| 30881792 | Background | Ducic I, Yoon J, Momeni A, Ahcan U. Anatomical Considerations to Optimize Sensory Recovery in Breast Neurotization with Allograft. Plast Reconstr Surg Glob Open. 2018 Nov 7;6(11):e1985. doi: 10.1097/GOX.0000000000001985. eCollection 2018 Nov. |
| 25289267 | Background | Spiegel AJ, Menn ZK, Eldor L, Kaufman Y, Dellon AL. Breast Reinnervation: DIEP Neurotization Using the Third Anterior Intercostal Nerve. Plast Reconstr Surg Glob Open. 2013 Dec 6;1(8):e72. doi: 10.1097/GOX.0000000000000008. eCollection 2013 Nov. |
| 31348332 | Background | Beugels J, Cornelissen AJM, van Kuijk SMJ, Lataster A, Heuts EM, Piatkowski A, Spiegel AJ, van der Hulst RRWJ, Tuinder SMH. Sensory Recovery of the Breast following Innervated and Noninnervated DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2019 Aug;144(2):178e-188e. doi: 10.1097/PRS.0000000000005802. |
| 33634007 | Background | Hamilton KL, Kania KE, Spiegel AJ. Post-mastectomy sensory recovery and restoration. Gland Surg. 2021 Jan;10(1):494-497. doi: 10.21037/gs.2020.03.22. |
| 32346819 | Background | Bijkerk E, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Breast sensibility in bilateral autologous breast reconstruction with unilateral sensory nerve coaptation. Breast Cancer Res Treat. 2020 Jun;181(3):599-610. doi: 10.1007/s10549-020-05645-y. Epub 2020 Apr 28. |