Mutter Didier, Callari Cosimo, D Agostino Jacopo, Cahill Ronan A, Forgione Antonello, Vix Michel, Leroy Joël, Marescaux Jacques
Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France.
Surg Technol Int. 2010 Apr;19:105-10.
Prosthetic material composition is implicated in the phenomenon of postoperative chronic groin pain that has undermined elective open inguinal herniorrhaphy. Reported herein are our 'all-comers' experiences with a novel dual component mesh (4DDome(R)). A prospective cohort (Phase II) study was performed that involved all patients undergoing elective open inguinal herniorrhaphy during a four-year period. Conventional operative technique was used except for choice of prosthesis. The 4DDome mesh comprises a molded dome-shaped composite (10% polypropylene, 90% poly-L-lactic acid) with a lightweight polypropylene mesh overlay. Short- (1 week) and intermediate-term (18 months) clinical follow-up with examination and symptom questionnaire judged outcome while surgeons rated their approval using a visual analogue scale. One hundred ninety-six patients (mean age, 65.5 years; Mean BMI, 25.5; Mean ASA, 1.8, 178 males) underwent repair of 201 inguinal hernias by six surgeons (three residents). The majority of patients had an indirect hernia (n=119) 93 being combined with a posterior wall defect [Nyhus IIIa], whereas 66 had a direct hernia [Nyhus IIIb], and 11 had a recurrent hernia.) Mean operative time was 44.6 minutes with 92 patients being operated under local anesthesia. Ten patients developed seromas and two had hematomas early postoperatively. Median intermediate-term follow-up is currently 19 (range: 3-72) months for the 147 (75%) patients still available for contact. The incidence of chronic groin pain is 8.8%, whereas there has been one hernia recurrence. Surgeon satisfaction and confidence were high. The 4DDome provides appropriate clinical results and, therefore, appears valid for use in routine practice.
人工合成材料的成分与术后慢性腹股沟疼痛现象有关，而这一现象已经对选择性开放腹股沟疝修补术造成了不利影响。本文报告了我们使用新型双组分补片（4DDome®）治疗所有患者的经验。我们进行了一项前瞻性队列（II期）研究，纳入了在四年期间内所有接受选择性开放腹股沟疝修补术的患者。除了假体的选择外，采用传统手术技术。4DDome补片由一个模制的圆顶形复合材料（10%聚丙烯，90%聚-L-乳酸）和一个轻质聚丙烯网片覆盖层组成。通过检查和症状问卷进行短期（1周）和中期（18个月）临床随访来判断结果，同时外科医生使用视觉模拟量表对其满意度进行评分。196例患者（平均年龄65.5岁；平均体重指数25.5；平均美国麻醉医师协会分级1.8，178例男性）由6名外科医生（3名住院医师）进行了201例腹股沟疝修补术。大多数患者为间接疝（n=119），其中93例合并后壁缺损[Nyhus IIIa型]，而66例为直疝[Nyhus IIIb型]，11例为复发性疝。平均手术时间为44.6分钟，92例患者在局部麻醉下进行手术。10例患者术后早期出现血清肿，2例出现血肿。目前，147例（75%）仍可联系到的患者的中期随访中位数为19个月（范围：3 - 72个月）。慢性腹股沟疼痛的发生率为8.8%，而有1例疝复发。外科医生的满意度和信心较高。4DDome补片提供了合适的临床效果，因此似乎可有效用于常规临床实践。
