Prospective double-blind randomized controlled study comparing heavy- and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results
Prospective double-blind randomized controlled study comparing heavy- and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results
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DOI：
10.1007/s00464-008-0188-2
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发表时间：
2009-02-01
影响因子：
3.1
通讯作者：
Mahajan, Krishan C.
中科院分区：
文献类型：
--
作者：
Agarwal, Brij B.;Agarwal, Krishna Adit;Mahajan, Krishan C.
完全腹膜外（TEP）腹股沟疝修补术的成功取决于通过炎症导致网状腱膜瘢痕组织（MAST）复合体形成来加强弱化的天然组织。可归因于补片中聚丙烯（PP）含量的炎症反应与PP重量和补片孔径相关。MAST复合物形成后炎症过程的继续可截留相邻结构，导致不良结局，如腹股沟疼痛。在动物研究中，PP含量的降低已显示出有益。由于缺乏对人类的随机对照试验（RCT），因此只能根据外科医生的偏好或成本来选择补片。我们进行了一项双盲随机对照试验，比较了重型和轻型PP基补片在TEP中的应用。在符合伦理和知情同意协议的情况下，入选了接受双侧TEP疝修补术的已婚、性生活活跃的男性候选人，无任何排除。日托手术遵循标准TEP技术。在每例患者中植入重型和轻型补片，随机分组后在任一腹股沟植入一个。外科医生和患者对腹股沟侧和补片类型不知情。一名独立医生（AID）评估患者的腹股沟疼痛、不适、性功能障碍和临床复发。一名非医学秘书/AID将AID收集的两侧腹股沟的前瞻性数据转移到Microsoft Excel中。从2005年12月至2007年7月，对25例双侧TEP植入25个重型和25个轻型PP补片，每例患者各植入一个，无困难或并发症。轻质PP补片与显著更好的疼痛评分、患者舒适度和性功能相关。两种补片均无感染或复发。与重型PP补片相比，轻型PP补片在TEP腹股沟疝修补术中的结局显著更好。
Success of totally extraperitoneal (TEP) inguinal herniorrhaphy depends upon strengthening of the weakened native tissue by inflammation resulting in mesh-aponeurosis scar tissue (MAST) complex formation. The inflammatory response attributable to polypropylene (PP) content of the mesh is linked to weight of PP and pore size of the mesh. Continuation of the inflammatory process beyond MAST complex formation can entrap contiguous structures, leading to adverse outcome such as groin pain. Reduction of PP content has been shown to be beneficial in animal studies. Paucity of randomized controlled trials (RCTs) on human beings has left choice of mesh to surgeon preference or cost. We carried out a double-blind RCT comparing heavy- and lightweight PP-based meshes in TEP.Consecutive, married, sexually active male candidates for bilateral TEP herniorrhaphy were enrolled without any exclusion, with ethical and informed consent protocol. Standard TEP technique was followed for day-care surgery. Heavy- and lightweight meshes were implanted in each patient, one in either groin after randomization. Surgeon and patient were blinded to side of groin and type of mesh. An independent doctor (AID) evaluated the patients for groin pain, discomfort, sexual dysfunction, and clinical recurrence. A nonmedical secretary/AID transferred prospective data for both sides of groin collected by AID to Microsoft Excel.Twenty-five bilateral TEPs implanting 25 heavy- and 25 lightweight PP meshes, one of each type in each patient, were performed from December 2005 to July 2007 without difficulty or complication. Lightweight PP mesh was associated with significantly better pain scores, patient comfort, and sexual function. There was no infection or recurrence with either type of mesh.Lightweight PP mesh is associated with significantly better outcomes in TEP inguinal herniorrhaphy as compared with heavyweight PP mesh.