开放式与机器人辅助肌后腹疝修补术：ORREO前瞻性随机对照试验的结果
Open versus robotic retromuscular ventral hernia repair: outcomes of the ORREO prospective randomized controlled trial.
作者信息
Warren Jeremy A, Blackhurst Dawn, Ewing Joseph A, Carbonell Alfredo M
机构信息
Prisma Health Department of Surgery, University of South Carolina School of Medicine Greenville, 701 Grove Rd, ST 3, Greenville, SC, 29605, USA.
Prisma Health Research Administration, Greenville, SC, USA.
出版信息
Surg Endosc. 2024 Dec;38(12):7466-7474. doi: 10.1007/s00464-024-11202-1. Epub 2024 Sep 12.
BACKGROUND
Robotic retromuscular ventral hernia repair (rRMVHR) potentially combines the best features of open and minimally invasive VHR: myofascial release with abdominal wall reconstruction (AWR) with the lower wound morbidity of laparoscopic VHR. Proliferation of this technique has outpaced the data supporting this claim. We report 2-year outcomes of the first randomized controlled trial of oRMVHR vs rRMVHR.
METHODS
Single-center randomized control trial of open vs rRMVHR. 100 patients were randomized (50 open, 50 robotic). We included patients > 18 y/o with hernias 7-15 cm with at least one of the following: diabetes, chronic obstructive pulmonary disease (COPD), body mass index (BMI) ≥ 30, or current smokers. Primary outcome was occurrence of a composite outcome of surgical site infection (SSI), non-seroma surgical site occurrence (SSO), readmission, or hernia recurrence. Secondary outcomes were length of stay, any SSI or SSO, SSI/SSOPI, operative time, patient reported quality of life, and cost. Analysis was performed in an intention-to-treat fashion. Study was funded by a grant from Society of American Gastrointestinal and Endoscopic Surgeons.
RESULTS
90 patients were available for 30-day and 62 for 2-year analysis (rRMVHR = 46 and 32, oRMVHR = 44 and 30). Hernias in the open group were slightly larger (10 vs 8 cm, p = 0.024) and more likely to have prior mesh (36.4 vs 15.2%; p = 0.030), but were similar in length, prior hernia repairs, mesh use, and myofascial release. There was no difference in primary composite outcome between oRMVHR and rRMVHR (20.5 vs 19.6%, p = 1.000). Median length of stay was shorter for rRMVHR (1 vs 2 days; p < 0.001). All patients had significant improvement in quality of life at 1 and 2 years. Other secondary outcomes were similar.
CONCLUSION
There is no difference in a composite outcome including SSI, SSOPI, readmission, and hernia recurrence between open and robotic RMVHR.
背景
机器人肌后腹疝修补术（rRMVHR）可能结合了开放和微创腹疝修补术的最佳特点：肌筋膜松解联合腹壁重建（AWR），同时具有腹腔镜腹疝修补术较低的伤口发病率。这项技术的推广速度超过了支持这一说法的数据。我们报告了开放手术与机器人手术治疗复发性肌后腹疝（oRMVHR与rRMVHR）的第一项随机对照试验的2年结果。
方法
开放手术与rRMVHR的单中心随机对照试验。100例患者被随机分组（50例开放手术，50例机器人手术）。我们纳入了年龄大于18岁、疝大小为7-15厘米且具有以下至少一项特征的患者：糖尿病、慢性阻塞性肺疾病（COPD）、体重指数（BMI）≥30或当前吸烟者。主要结局是手术部位感染（SSI）、非血清肿手术部位事件（SSO）、再入院或疝复发的复合结局的发生情况。次要结局包括住院时间、任何SSI或SSO、SSI/SSOPI、手术时间、患者报告的生活质量和费用。分析采用意向性分析方法。该研究由美国胃肠和内镜外科医生协会的一项拨款资助。
结果
90例患者可进行30天分析，62例可进行2年分析（rRMVHR组=46例和32例，oRMVHR组=44例和30例）。开放手术组的疝稍大（10厘米对8厘米，p=0.024），且更可能有既往补片使用史（36.4%对15.2%；p=0.030），但在病程、既往疝修补次数、补片使用和肌筋膜松解方面相似。oRMVHR与rRMVHR之间的主要复合结局无差异（20.5%对19.6%，p=1.000）。rRMVHR的中位住院时间较短（1天对2天；p<0.001）。所有患者在1年和2年时生活质量均有显著改善。其他次要结局相似。
结论
开放手术与机器人手术治疗RMVHR在包括SSI、SSOPI、再入院和疝复发的复合结局方面无差异。
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