Department of Surgery, Section of Acute and Critical Care Surgery, Washington University in St Louis, St Louis, MO.
Baltimore VA Medical Center, Baltimore, MD.
J Am Coll Surg. 2014 Apr;218(4):751-7. doi: 10.1016/j.jamcollsurg.2014.01.043. Epub 2014 Feb 3.
Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique.
A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected.
One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons.
The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes.
各种外科补片用于腹股沟疝修补，与多种并发症相关。我们的主要目标是确定生物疝基质在使用 Lichtenstein 技术的开放式腹股沟疝修补中是否与聚丙烯补片等效。
进行了一项前瞻性、随机、双盲、单中心试验，以评估生物腹股沟疝基质（IHM；库克医疗）与聚丙烯（PP）网片在 3 年结果研究中使用 Lichtenstein 腹股沟疝修补的疗效。通过盲法外科医生在术后 2 周、3 个月、6 个月和 1 年评估患者的复发和并发症情况。记录患者的人口统计学资料，包括合并症和营养状况。收集术中信息，包括疝类型和位置、手术时间、手术难度、外科医生的挫败感程度和手术经验。
100 名男性患者提供了知情同意并以 1:1 的比例随机入组。两组之间的手术难度和挫败感程度没有显著差异。在 1 年随访时，IHM 组有 3 例复发，而 PP 组无复发（p = 0.11）。PP 组持续性疼痛发生率较高（6%比 4%）。所有 3 例复发均发生在直接腹股沟疝组，且均由培训后第 1 年的主治医生进行（3 位不同的主治医生）。没有复发发生在由更高级别的外科医生进行手术的患者中。
在 1 年随访时，IHM 疝修补术与 PP 网片相比具有相似的复发率和并发症发生率。外科医生的经验似乎是影响手术成功的主要因素。
