Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques

Официальное название

Sensory Restoration in DIEP Free Flaps for Post-Mastectomy Breast Reconstruction After Breast Cancer: Comparing Non-sensitized Standard Technique to Direct Nerve Suture and to Autograft: A Three-arm, Randomized, Double-blinded Superiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Semmes-Weinstein-Monofilament-Test [Срок оценки: At 12-months-follow-up]

Вторичные конечные точки (12)

• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Sensory recovery to DIEP flap [Срок оценки: 12 months postop]
• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Sensory recovery to DIEP flap [Срок оценки: 12 months postop]
• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Sensory recovery to DIEP flap [Срок оценки: 12 months postop]
• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Sensory recovery to DIEP flap [Срок оценки: 12 months postop]
• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Sensory recovery to DIEP flap [Срок оценки: 12 months postop]
• Change in breast sensation [Срок оценки: day-1/1week/3/6/12/24 months postop]
• Breast-specific health-related QoL [Срок оценки: 12 months postop]

Критерии участия

A) Pilot study

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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

Критерии исключения

• autologous reconstruction where the flap is completely buried
• patients in need of both-sided reconstruction (double DIEP)
• 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 at time of planned DIEP flap surgery and lactation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Geneva University Hospitals — Geneva

Публикации

• 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. PMID 28673764
• 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. PMID 10343589
• 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. PMID 19116520
• 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. PMID 35993852
• 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. PMID 35872020
• 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. PMID 30881792
• 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. PMID 25289267
• 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. PMID 31348332

Идентификаторы

NCT: NCT06930378 · SNCTP000006257 · BASEC2024-02109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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