Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.
Incisional hernia is a frequent complication after open abdominal surgery. Prophylactic mesh implantation in the onlay or sublay position requires dissection of the abdominal wall, potentially leading to wound-associated complications.
To compare the incidence of incisional hernia among patients after prophylactic intraperitoneal mesh implantation with that among patients after standard abdominal closure.
DESIGN, SETTING, AND PARTICIPANTS: An open-label randomized clinical trial was performed in 169 patients undergoing elective open abdominal surgery from January 1, 2011, to February 29, 2014. Follow-up examinations were performed 1 year and 3 years after surgery. The study was conducted at Bern University Hospital, Bern, Switzerland, a referral center that offers the whole spectrum of abdominal surgical interventions. Patients with 2 or more of the following risk factors were included: overweight or obesity, diagnosis of neoplastic disease, male sex, or history of previous laparotomy. Patients were randomly assigned to prophylactic intraperitoneal mesh implantation or standard abdominal closure. Data were analyzed in August 2017.
Intraperitoneal implantation of a polypropylene-polyvinylidene fluoride mesh with circumferential fixation.
The primary end point was the incidence of incisional hernia 3 years after surgery. Secondary end points included mesh-related complications.
After the exclusion of 19 patients, 150 patients (81 in the control group and 69 in the mesh group; mean [SD] age, 64.2 [11.1] years; 102 [68.0%] male) were studied. The cumulative incidence of incisional hernia was significantly lower in the mesh group compared with the control group (5 of 69 [7.2%] vs 15 of 81 [18.5%], log-rank test P = .03). Abdominal pain was observed in significantly more patients in the mesh group compared with the control group at 6 weeks (34 of 52 [65%] vs 26 of 59 [44%], P = .04) but not at 12 and 36 months postoperatively. No difference in surgical site infections was observed, but time to complete wound healing of surgical site infection was significantly longer in patients with mesh implantation (median [interquartile range], 8 [6-24] weeks compared with 5 [1-9] weeks; P = .03). Trunk extension was significantly decreased after mesh implantation compared with the control group (mean [SD], 1.73 [0.97] cm vs 2.40 [1.23] cm, P = .009).
In patients at elevated risk for incisional hernia, prophylactic intraperitoneal mesh implantation reduces the incidence of hernia formation but with increased early postoperative pain and prolonged wound healing of surgical site infection.
ClinicalTrials.gov Identifier: NCT01203553.
切口疝是腹部开放性手术后常见的并发症。在层铺或下铺位置预防性植入网片需要对腹壁进行解剖，这可能导致与伤口相关的并发症。
比较预防性腹腔内网片植入患者与标准腹部关闭患者术后切口疝的发生率。
设计、设置和参与者：2011 年 1 月 1 日至 2014 年 2 月 29 日，对 169 例接受择期腹部开放性手术的患者进行了一项开放标签随机临床试验。术后 1 年和 3 年进行随访检查。该研究在瑞士伯尔尼大学医院进行，该医院是一家提供全腹部外科干预的转诊中心。纳入有以下 2 种或 2 种以上危险因素的患者：超重或肥胖、诊断为肿瘤疾病、男性或既往剖腹手术史。患者被随机分配到预防性腹腔内网片植入组或标准腹部关闭组。数据于 2017 年 8 月进行分析。
聚丙稀-聚偏氟乙烯网片的腹腔内植入，并进行圆周固定。
主要终点是术后 3 年切口疝的发生率。次要终点包括与网片相关的并发症。
排除 19 例患者后，共纳入 150 例患者（对照组 81 例，网片组 69 例；平均[标准差]年龄 64.2[11.1]岁；102 例[68.0%]为男性）。与对照组相比，网片组的切口疝累积发生率明显较低（5 例[7.2%]比 15 例[18.5%]，对数秩检验 P = .03）。与对照组相比，网片组在术后 6 周时疼痛明显更常见（52 例中的 34 例[65%]比 59 例中的 26 例[44%]，P = .04），但在术后 12 个月和 36 个月时无差异。两组手术部位感染无差异，但网片植入患者的手术部位感染完全愈合时间明显较长（中位数[四分位间距]：8 [6-24]周比 5 [1-9]周；P = .03）。与对照组相比，网片植入后躯干伸展明显减少（平均[标准差]：1.73 [0.97]cm比 2.40 [1.23]cm，P = .009）。
在有切口疝高风险的患者中，预防性腹腔内网片植入可降低疝形成的发生率，但会增加术后早期疼痛和手术部位感染的愈合时间。
ClinicalTrials.gov 标识符：NCT01203553。
