Bergström Mathias, Widhe Björn, Granåsen Gabriel, Löf Granström Anna, Ohlsson Johan, Schult Simone, Dahlstrand Ursula, Österberg Johanna, Loogna Peter, Bringman Sven, Melkemichel Maria
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, Södertälje Hospital, Södertalje, Sweden.
BJS Open. 2024 Dec 30;9(1). doi: 10.1093/bjsopen/zrae173.
Mesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet current evidence remains limited for smaller umbilical hernias. Important questions concern optimal mesh positioning and wound complications/surgical-site occurrences. The aim of this study was to report the preliminary results of a trial investigating surgical-site occurrences in suture versus mesh repair for umbilical hernias less than or equal to 2 cm.
A randomized, controlled, parallel-group, double-blind, multicentre trial across six Swedish surgical units is comparing 4 × 4 cm macroporous lightweight onlay mesh repair with conventional suture repair for primary elective umbilical hernias less than or equal to 2 cm. Intraoperative centralized web-based randomization ensured allocation concealment. The primary outcome of the trial is recurrence at 3 years, whereas secondary outcomes (the focus of this study) include surgical-site occurrences and pain intensity at 30 days post-surgery.
From February 2020 to January 2024, 290 participants were randomly assigned to either suture or mesh repair. After exclusion and loss to follow-up, the remaining population for analysis was 144 participants for suture repair and 135 participants for mesh repair. Surgical-site occurrences (Clavien-Dindo grade greater than or equal to I) affected 32 mesh repair participants (23.7%) compared with 26 suture repair participants (18.1%), without any significant increase in surgical-site occurrences for mesh repair (OR 1.39 (95% c.i. 0.78 to 2.51)). Clinically relevant surgical-site occurrences (Clavien-Dindo grade greater than or equal to II) were less common in the mesh group (2 participants; 1.5%) compared with the suture group (4 participants; 2.8%). The median duration of surgery was 32 min for suture repair and 45 min for mesh repair (P < 0.001). Assessment of pain intensity revealed that 82.0% of suture repair participants and 73.0% of mesh repair participants reported no pain (P = 0.061).
This randomized clinical trial provides high-level evidence for mesh repair for umbilical hernias less than or equal to 2 cm. With regard to early postoperative outcomes, such as surgical-site occurrences, onlay mesh repair can be considered comparable to suture repair and is safe to use for smaller umbilical hernias.
NCT04231071 (http://www.clinicaltrials.gov).
对于直径大于1厘米的脐疝，建议采用补片修补术以降低复发率，但目前关于较小脐疝的证据仍然有限。重要问题涉及补片的最佳放置位置以及伤口并发症/手术部位事件。本研究的目的是报告一项试验的初步结果，该试验调查了直径小于或等于2厘米的脐疝采用缝线修补与补片修补的手术部位事件。
一项在瑞典6个外科手术单元进行的随机、对照、平行组、双盲、多中心试验，正在比较4×4厘米大孔轻质覆盖补片修补术与传统缝线修补术治疗直径小于或等于2厘米的原发性择期脐疝的效果。术中基于网络的集中随机化确保了分配隐藏。该试验的主要结局是3年时的复发情况，而次要结局（本研究的重点）包括术后30天的手术部位事件和疼痛强度。
从2020年2月到2024年1月，290名参与者被随机分配接受缝线修补或补片修补。经过排除和失访后，用于分析的剩余人群为144名接受缝线修补的参与者和135名接受补片修补的参与者。手术部位事件（Clavien-Dindo分级大于或等于I级）影响了32名接受补片修补的参与者（23.7%），而接受缝线修补的参与者有26名（18.1%），补片修补的手术部位事件没有显著增加（比值比1.39（95%置信区间0.78至2.51））。与缝线组（4名参与者；2.8%）相比，临床上相关的手术部位事件（Clavien-Dindo分级大于或等于II级）在补片组中较少见（2名参与者；1.5%）。缝线修补的中位手术时间为32分钟，补片修补为45分钟（P<0.001）。疼痛强度评估显示，82.0%的缝线修补参与者和73.0%的补片修补参与者报告无疼痛（P=0.061）。
这项随机临床试验为直径小于或等于2厘米的脐疝补片修补提供了高级别证据。关于术后早期结局，如手术部位事件，覆盖补片修补可被认为与缝线修补相当，并且对于较小的脐疝使用是安全的。
NCT04231071（http://www.clinicaltrials.gov）
