开放式腹股沟疝修补术与机器人腹股沟疝修补术:ORREO 前瞻性随机对照试验的结果

Jeremy A. Warren, Dawn Blackhurst, Joseph A. Ewing, Alfredo M. Carbonell
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引用次数: 0

摘要

背景机械再肌力腹股沟疝修补术(rRMVHR)可能结合了开放式腹股沟疝修补术和微创腹股沟疝修补术的最佳特点:肌筋膜松解和腹壁重建(AWR),以及腹腔镜腹股沟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。我们报告了首次随机对照试验中开腹腹壁肌肉松解术与腹壁肌肉松解术的两年结果。100名患者被随机分配(50名开放式患者,50名机器人患者)。我们纳入了年龄在 18 岁以上、疝长 7-15 厘米、至少患有以下一种疾病的患者:糖尿病、慢性阻塞性肺病(COPD)、体重指数(BMI)≥ 30 或吸烟者。主要结果是手术部位感染(SSI)、非血清瘤手术部位感染(SSO)、再入院或疝气复发的综合结果。次要结果是住院时间、任何 SSI 或 SSO、SSI/SSOPI、手术时间、患者报告的生活质量和费用。分析以意向治疗方式进行。研究得到了美国胃肠道内镜外科医生学会的资助。结果90例患者可进行30天分析,62例可进行2年分析(rRMVHR=46和32,oRMVHR=44和30)。开放手术组的疝气稍大(10 cm 对 8 cm,p = 0.024),更有可能使用过网片(36.4% 对 15.2%;p = 0.030),但在长度、之前的疝气修复、网片使用和肌筋膜松解方面相似。oRMVHR 和 rRMVHR 的主要综合结果没有差异(20.5% vs 19.6%,p = 1.000)。rRMVHR 的中位住院时间更短(1 天 vs 2 天;p < 0.001)。所有患者在 1 年和 2 年后的生活质量都有明显改善。结论开腹和机器人RMVHR在SSI、SSOPI、再入院和疝复发等综合结果上没有差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Open versus robotic retromuscular ventral hernia repair: outcomes of the ORREO prospective randomized controlled trial

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.

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