Tamme C, Garde N, Klingler A, Hampe C, Wunder R, Köckerling F
Department of Surgery, Center for Minimally Invasive Surgery, Hanover, Hospital, Roesebeckstrasse 15 (Siloah), 30449 Hanover, Germany.
Surg Endosc. 2005 Aug;19(8):1125-9. doi: 10.1007/s00464-004-8219-0. Epub 2005 May 26.
This prospective study of a new titanium-coated low-weight polypropylene (PP) mesh (16 g PP/m2) was designed to investigate the clinical efficacy and safety of totally extraperitoneal endoscopic hernioplasty (TEP).
In this study, 400 patients (average age, 53.5 years; range, 19-80 years) with a total of 588 inguinal hernias underwent surgery with the TEP technique between September 2002 and October 2003. Of these patients, 12.4% had experienced recurrent hernias after open suture herniotomy. In 92% of the cases (368 patients with 540 hernias), a lightweight (16 g PP/m2) titanium-coated polypropylene mesh was implanted without fixation, and in 8% (32 patients with 48 hernias) an identical medium-weight (35 g PP/m2) mesh was implanted. The first follow-up examination was scheduled for postoperative week 6.
In the lightweight mesh group, the mean group, operating time per patient was 61 min, corresponding to a calculated time per hernia of 41 min. Two intraoperative major complications occurred: an injury to the cecum and an injury to the bladder. In 12 cases (2%), bleeding from epigastric, testicular, or pubic bone vessels was observed. No injuries to pelvic vessels were seen. One patient was underwent an endoscopic revision to deal with an anticoagulation-related bleed. The mortality rate was 0%. In 12 patients, postoperative hematomas developed. One preperitoneal lipoma had to be extirpated. No infections of the mesh occurred. The median follow-up period for 371 patients (92.3%) was 7.2 weeks (range, 4-14 weeks). These 343 patients (with 504 hernias) had been provided with a lightweight titanium-coated polypropylene mesh (16 g PP/m2) (follow-up rate, 93.2%). Of these patients, 3.5% reported persistent ingunial pain, 1.7% described a sensation of rigidity in the region of the groin, and 3.2% reported dysesthesia. The early recurrence rate was 0.2%.
The TEP procedure can be performed safely and effectively with the appreciably material-reduced and titanium-coated polypropylene mesh without the need for fixation of the implant. The low early recurrence rate of 0.2% is evidence that the posterior wall of the inguinal canal is adequately augmented. The question whether the material reduction and the titanium coating of the mesh may bring about a reduction in postoperative chronic pain and the sensation of rigidity in the inguinal area via an improvement in biocompatibility must await the results of the scheduled follow-up examination 1 year after the surgical procedure.
本前瞻性研究针对一种新型钛涂层低重量聚丙烯(PP)补片(16 g PP/m²),旨在探讨完全腹膜外内镜疝修补术(TEP)的临床疗效及安全性。
本研究中,2002年9月至2003年10月期间,400例患者(平均年龄53.5岁;范围19 - 80岁)共588例腹股沟疝接受了TEP技术手术。其中,12.4%的患者在开放缝合疝修补术后出现复发性疝。92%的病例(368例患者共540例疝)植入了轻质(16 g PP/m²)钛涂层聚丙烯补片且未进行固定,8%(32例患者共48例疝)植入了相同的中重量(35 g PP/m²)补片。首次随访检查定于术后第6周进行。
在轻质补片组,平均每位患者的手术时间为61分钟,据此计算每例疝的手术时间为41分钟。术中发生了2例主要并发症:1例盲肠损伤和1例膀胱损伤。12例(2%)患者出现来自腹壁上动脉、睾丸或耻骨血管的出血。未见盆腔血管损伤。1例患者因抗凝相关出血接受了内镜下修复手术。死亡率为0%。12例患者术后出现血肿。1例腹膜前脂肪瘤需切除。未发生补片感染。371例患者(92.3%)的中位随访期为7.2周(范围4 - 14周)。这343例患者(共504例疝)植入的是轻质钛涂层聚丙烯补片(16 g PP/m²)(随访率93.2%)。其中,3.5%的患者报告有持续性腹股沟疼痛,1.7%的患者描述腹股沟区域有僵硬感,3.2%的患者报告有感觉异常。早期复发率为0.2%。
使用显著减少材料并带有钛涂层的聚丙烯补片,无需固定植入物,TEP手术可安全有效地进行。0.2%的低早期复发率证明腹股沟管后壁得到了充分加强。补片材料减少及钛涂层是否可通过改善生物相容性降低术后慢性疼痛和腹股沟区僵硬感的问题,有待手术1年后预定随访检查的结果。