腹腔镜与机器人腹股沟疝修补术:RIVAL试验的1年和2年结果
Laparoscopic versus robotic inguinal hernia repair: 1- and 2-year outcomes from the RIVAL trial.
作者信息
Miller Benjamin T, Prabhu Ajita S, Petro Clayton C, Beffa Lucas R A, Carbonell Alfredo M, Hope William, Warren Jeremy, Higgins Rana M, Jacob Brian, Blatnik Jeffrey, Krpata David M, Tu Chao, Costanzo Adele, Rosen Michael J
机构信息
Cleveland Clinic Center for Abdominal Core Health, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
Department of Surgery, Prisma Health-Upstate, University of South Carolina School of Medicine, Greenville, SC, USA.
出版信息
Surg Endosc. 2023 Jan;37(1):723-728. doi: 10.1007/s00464-022-09320-9. Epub 2022 May 16.
INTRODUCTION
Robotic inguinal hernia repair is growing in popularity among general surgeons despite little high-quality evidence supporting short- or long-term advantages over traditional laparoscopic inguinal hernia repair. The original RIVAL trial showed increased operative time, cost, and surgeon frustration for the robotic approach without advantages over laparoscopy. Here we report the 1- and 2-year outcomes of the trial.
METHODS
This is a multi-center, patient-blinded, randomized clinical study conducted at six sites from 2016 to 2019, comparing laparoscopic versus robotic transabdominal preperitoneal (TAPP) inguinal hernia repair with follow-up at 1 and 2 years. Outcomes include pain (visual analog scale), neuropathic pain (Leeds assessment of neuropathic symptoms and signs pain scale), wound morbidity, composite hernia recurrence (patient-reported and clinical exam), health-related quality of life (36-item short-form health survey), and physical activity (physical activity assessment tool).
RESULTS
Early trial participation included 102 patients; 83 (81%) completed 1-year follow-up (45 laparoscopic vs. 38 robotic) and 77 (75%) completed 2-year follow-up (43 laparoscopic vs. 34 robotic). At 1 and 2 years, pain was similar for both groups. No patients in either treatment arm experienced neuropathic pain. Health-related quality of life and physical activity were similar for both groups at 1 and 2 years. No long-term wound morbidity was seen for either repair type. At 2 years, there was no difference in hernia recurrence (1 laparoscopic vs. 1 robotic; P = 1.0).
CONCLUSIONS
Laparoscopic and robotic inguinal hernia repairs have similar long-term outcomes when performed by surgeons with experience in minimally invasive inguinal hernia repairs.
引言
尽管几乎没有高质量证据支持机器人腹股沟疝修补术相较于传统腹腔镜腹股沟疝修补术在短期或长期具有优势,但该手术在普通外科医生中越来越受欢迎。最初的RIVAL试验表明,机器人手术方式增加了手术时间、成本,且让外科医生感到挫败,并未显示出优于腹腔镜手术的优势。在此,我们报告该试验的1年和2年结果。
方法
这是一项多中心、患者盲法、随机临床研究,于2016年至2019年在六个地点进行,比较腹腔镜与机器人经腹腹膜前(TAPP)腹股沟疝修补术,并进行1年和2年的随访。结果包括疼痛(视觉模拟量表)、神经性疼痛(利兹神经性症状和体征疼痛量表)、伤口并发症、复合疝复发(患者报告和临床检查)、健康相关生活质量(36项简短健康调查问卷)以及身体活动(身体活动评估工具)。
结果
早期试验参与者有102例患者;83例(81%)完成了1年随访(45例腹腔镜手术 vs. 38例机器人手术),77例(75%)完成了2年随访(43例腹腔镜手术 vs. 34例机器人手术)。在1年和2年时,两组疼痛情况相似。两个治疗组均无患者出现神经性疼痛。在1年和2年时,两组的健康相关生活质量和身体活动情况相似。两种修复类型均未出现长期伤口并发症。在2年时,疝复发情况无差异(腹腔镜手术1例 vs. 机器人手术1例;P = 1.0)。
结论
对于有微创腹股沟疝修补经验的外科医生而言,腹腔镜和机器人腹股沟疝修补术具有相似的长期效果。