ImportanceDurable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations.ObjectiveTo determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates.Design, Setting, and ParticipantsIn this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years.InterventionsFollowing intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement.Main Outcomes and MeasuresThe primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall–specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years.ResultsA total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, −0.029; 95% CI, −0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall–specific quality of life, stoma-specific quality of life, and decision regret at any time point.Conclusions and RelevanceIn the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes.Trial RegistrationClinicalTrials.gov Identifier: NCT03972553

中文翻译：

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开放式肌肉后 Sugarbaker 与锁孔网放置用于造口旁疝修复


重要性 持久的造口旁疝修复仍然难以实现。比较开放式肌后 Sugarbaker 和锁孔网片配置的耐用性的证据有限。目的确定开放式肌后 Sugarbaker 网片放置技术是否会降低造口旁疝复发率。设计、设置和参与者在这项单中心、随机临床试验中，150 2019 年 4 月至 2022 年 4 月期间，对具有永久性造口和相关造口旁疝的患者进行开放性肌后造口旁疝修补术的入组和随机分组，并随访 2 年。 干预措施 在术中评估以确定任一技术的可行性后，对入组患者进行随机分组接受肌后 Sugarbaker 或锁孔合成网片放置。 主要结果和措施 主要结果是 2 年时造口旁疝复发。次要结局包括补片相关并发症、伤口并发症、再次手术以及患者报告的疼痛、腹壁特定生活质量、造口特定生活质量以及 1 年和 2 年的决策后悔。 结果总计 150患者被随机分组​​，2 年随访率为 91%，肌后 Sugarbaker 组有 13 例 (17%) 造口旁疝复发，锁孔组有 18 例 (24%)（调整后风险差，-0.029；95%） CI，-0.17 至 0.153，调整后的风险比，0.87；95% CI，0.42 至 1.69）。 Sugarbaker 组和锁孔组在复发再次手术（分别为 2 例和 7 例）、非疝气腹腔内病理学（分别为 4 例和 10 例）、造口坏死（分别为 1 例和 0 例）、补片相关性方面没有统计学上的显着差异。并发症（分别为 4 比 1）、患者报告的疼痛、腹壁特定的生活质量、造口特定的生活质量以及任何时间点的决策后悔。结论和相关性在开放性造口旁疝修补术中，肌后修复后 2 年后，Sugarbaker 网放置技术并不优于锁孔配置。需要进一步创新来改善造口旁疝修复效果。试验注册临床试验。政府标识符： NCT03972553