一项回顾性研究评估 Permacol™ 外科植入物在切口疝和腹疝修复中的应用。
A retrospective study evaluating the use of Permacol™ surgical implant in incisional and ventral hernia repair.
机构信息
Loyola University, 2160 South First Ave., Maywood, IL 60153, USA.
Penn State Milton S. Hershey Medical Center, 500 University Drive, UPC I, Suite 3100, Hershey, PA 17033, USA.
出版信息
Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5.
BACKGROUND
The outcome of incisional and ventral hernia repair depends on surgical technique, patient, and material. Permacol™ surgical implant (crosslinked porcine collagen) has been used for over a decade; however, there are few data on outcomes. This study is the largest retrospective multinational study to date to evaluate outcomes with Permacol™ surgical implant in the repair of incisional and ventral hernias.
METHODS
Data were collected retrospectively on 343 patients treated for 213 incisional and 130 ventral hernias. Data evaluated included patient demographics, wound classification, surgical technique, morbidity, and recurrence rates.
RESULTS
Median follow-up time was 649 days (max: 2857), median age 57 years (range 23-91), and BMI 32 kg/m(2) (range 17.6-77.8). Two or more comorbidities were present in 70% of patients. Open surgery was performed in 220 (64%) patients. Permacol™ surgical implant was used as an underlay (250), sublay (39), onlay (37), or inlay (17). Surgical techniques included component separation (89; 25.9%), modified Stoppa technique (197; 57.4%), and Rives-Stoppa (17; 5.0%). CDC Surgical Wound Classification was Class I (190), Class II (103), Class III (28), and Class IV (22). Complications were seen in 40.5% (139) of the patients, with seroma (19%) and wound infection (15%) as the most common. Mesh removal occurred in 1 (0.3%) patient. Kaplan-Meier analysis demonstrated that the probabilities for hernia recurrence at one, two, and three years were 5.8%, 16.6%, and 31.0%, respectively.
CONCLUSIONS
Permacol™ surgical implant was shown to be safe with relatively low rates of hernia recurrence.
CLINICAL TRIAL REGISTRATION NUMBER
NCT01214252 (http://www.clinicaltrials.gov).
背景
切口疝和腹疝修补的结果取决于手术技术、患者和材料。Permacol™ 外科植入物（交联猪胶原蛋白）已使用了十余年；然而，关于其结果的数据却很少。本研究是迄今为止评估 Permacol™ 外科植入物在治疗切口疝和腹疝中的应用的最大的回顾性多国研究。
方法
对 343 例接受 213 例切口疝和 130 例腹疝治疗的患者进行了回顾性数据收集。评估的数据包括患者人口统计学、伤口分类、手术技术、发病率和复发率。
结果
中位随访时间为 649 天（最长 2857 天），中位年龄为 57 岁（范围 23-91 岁），BMI 为 32kg/m²（范围 17.6-77.8）。70%的患者存在两种或两种以上合并症。220 例（64%）患者接受了开放手术。Permacol™ 外科植入物作为底层（250 例）、中层（39 例）、上层（37 例）或衬里（17 例）使用。手术技术包括分离组件（89 例，25.9%）、改良 Stoppa 技术（197 例，57.4%）和 Rives-Stoppa（17 例，5.0%）。CDC 外科伤口分类为 I 类（190 例）、II 类（103 例）、III 类（28 例）和 IV 类（22 例）。40.5%（139 例）的患者出现并发症，最常见的是血清肿（19%）和伤口感染（15%）。1 例（0.3%）患者行网片取出术。Kaplan-Meier 分析表明，术后 1、2、3 年疝复发的概率分别为 5.8%、16.6%和 31.0%。
结论
Permacol™ 外科植入物安全，疝复发率相对较低。
临床试验注册号
NCT01214252（http://www.clinicaltrials.gov）。
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