Ruiz-Jasbon F, Norrby J, Ivarsson M-L, Björck S
Department of Surgery, Halland's Hospital, Kungsbacka, Sweden,
Hernia. 2014 Oct;18(5):723-30. doi: 10.1007/s10029-014-1249-1. Epub 2014 Apr 26.
Conventional meshes for hernia repair and abdominal wall reinforcement are usually made from polypropylene, polyester or other synthetic plastic materials known to promote foreign body reactions and a state of chronic inflammation that may lead to long-term complications. A novel approach is to use long-term resorbable implants like TIGR(®) Matrix Surgical Mesh. Preclinical studies have shown that this mesh maintains mechanical integrity beyond the point in time where newly formed tissue is capable of carrying the abdominal loads.
This was a first-in-man, prospective, pilot study performed during 2009, at two sites in Sweden. Forty patients with primary inguinal hernias were enrolled for Lichtenstein repair using TIGR(®) Matrix Surgical Mesh. The primary endpoint was safety as assessed by monitoring the incidence of adverse events and serious adverse events (SAEs) both related and unrelated to the mesh. The secondary endpoint was pain or discomfort. Visual Analogue Scale (VAS) 0-10 and Inguinal Pain Questionnaire were used for scoring pain and discomfort. Included patients have been followed for 36 months using ultrasound in combination with clinical examination.
All patients followed a normal early postoperative course. After 12 months no SAEs were reported. None of the patients with an isolated lateral inguinal hernia (LIH) had developed a recurrence but 4 (44 %) with medial and 4 (33 %) with combined hernias had recurred at 36-month follow-up. After 3-year follow-up none of the patients with LIH reported pain in the VAS-form and none of those patients could feel the sensation of a mesh in their groin. In the total study population 5 (16 %) patients experienced chronic pain in the form of mild sporadic pain and 3 (9.7 %) patients could feel the sensation of a mesh in their groin.
The use of a synthetic long-term resorbable mesh (TIGR(®) Matrix Surgical Mesh) in Lichtenstein repair was found to be safe, without recurrences, and promising regarding pain/discomfort at 3-year follow-up in patients with LIH. However, patients with medial and combined inguinal hernias had high recurrence rates.
用于疝修补和腹壁加强的传统补片通常由聚丙烯、聚酯或其他已知会引发异物反应和慢性炎症状态的合成塑料材料制成，这可能导致长期并发症。一种新方法是使用像TIGR（®）基质外科补片这样的长期可吸收植入物。临床前研究表明，这种补片在新形成的组织能够承受腹部负荷之后仍能保持机械完整性。
这是一项2009年在瑞典两个地点进行的首例人体前瞻性试点研究。40例原发性腹股沟疝患者入选，使用TIGR（®）基质外科补片进行Lichtenstein修补术。主要终点是安全性，通过监测与补片相关和不相关的不良事件及严重不良事件（SAE）的发生率来评估。次要终点是疼痛或不适。使用视觉模拟量表（VAS）0 - 10分和腹股沟疼痛问卷对疼痛和不适进行评分。纳入的患者通过超声结合临床检查进行了36个月的随访。
所有患者术后早期恢复正常。12个月后未报告严重不良事件。在36个月随访时，孤立性外侧腹股沟疝（LIH）患者无一复发，但内侧疝患者中有4例（44%）复发，复合疝患者中有4例（33%）复发。3年随访后，LIH患者中无人在VAS量表上报告疼痛，且这些患者中无人能在腹股沟处感觉到补片。在整个研究人群中，5例（16%）患者经历了轻度散发性疼痛形式的慢性疼痛，3例（9.7%）患者能在腹股沟处感觉到补片。
在Lichtenstein修补术中使用合成的长期可吸收补片（TIGR（®）基质外科补片）被发现是安全的，无复发情况，并且对于LIH患者在3年随访时的疼痛/不适方面前景良好。然而，内侧疝和复合性腹股沟疝患者的复发率较高。
