Department of Surgery, UD de Medicina de la Vall d'Hebron, Universitat Autonoma de Barcelona, Edifici W, Passeig Vall d'Hebron, Barcelona, 08035, Spain.
Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.
Trocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH.
A multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m and/or extended incision for specimen retrieval) who underwent either elective or emergency laparoscopic cholecystectomy. Patients were assigned to prophylactic onlay polypropylene mesh fixation (intervention) or to standard trocar closure (control). The main aim was to analyze the efficacy of the intervention, taking occurrence of TSIH as the primary outcome. Clinical and radiological follow up lasted at least one year after surgery. Secondary endpoints were technique-related complications (surgical site occurrences).
One hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294).
Our results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate.
ClinicalTrials.org NCT03495557. Date of registration: April 12, 2018.
套管部位切口疝（TSIH）是腹腔镜手术的常见并发症。在科学文献中，很少有关于预防方法或工具的描述。本报告的目的是评估一种旨在降低 TSIH 发生率的预防措施的有效性和安全性。
对患有糖尿病和/或年龄≥70 岁和/或 BMI≥30kg/m 和/或为取出标本而延长切口的高危患者（择期或急诊腹腔镜胆囊切除术）进行多中心随机双盲临床试验。患者被分配至预防性覆盖聚丙烯网片固定（干预组）或标准套管关闭（对照组）。主要目的是分析干预的效果，以 TSIH 的发生为主要结局。临床和放射学随访持续至少术后 1 年。次要终点是与技术相关的并发症（手术部位事件）。
共 143 名患者随机分组，最终有 116 名患者纳入分析（干预组 64 例，对照组 52 例）。两组之间具有可比性。平均（标准差）年龄为 65（18）岁，86 例（60.6%）为女性。尽管干预组的累积 TSIH 发生率较低，但差异无统计学意义（放射学评估：16 例[25.4%]与 17 例[31.5%]，p=0.538；临床评估：9 例[16.1%]与 9 例[20%]，p=0.613）。未发现手术部位感染、血肿或血清肿。平均随访时间为 670 天（范围 223-1294 天）。
我们的结果表明，当正确评估时，总体 TSIH 发生率极高。尽管聚丙烯网片覆盖放置是安全的，但似乎并不能有效降低 TSIH 发生率。放射学评估可能更准确。
ClinicalTrials.org NCT03495557。注册日期：2018 年 4 月 12 日。
