METHODS: This was a prospective phase 2a study following the IDEAL framework. Ten consecutive cases of RPD performed by two surgeons with expertise in open procedures at a single center were assigned to the study. With objective evaluation, each case was classified into four grades according to the achievements of the procedures. Errors observed in the previous case were used to inform the procedure in the next case. The surgical outcomes of the ten cases were reviewed.
RESULTS: The median total operation time was 634 min (interquartile range [IQR], 594-668) with a median resection time of 363 min (IQR, 323-428) and reconstruction time of 123 min (IQR, 107-131). The achievement of the whole procedure was graded as A, \"successful\", in two patients. In two patients, reconstruction was performed with a mini-laparotomy due to extensive pneumoperitoneum, probably caused by insertion of a liver retractor from the xyphoid. Major postoperative complications occurred in two patients. One patient, in whom the jejunal limb was elevated through the Treitz ligament, had a bowel obstruction and needed to undergo re-laparotomy.
CONCLUSIONS: RPD is feasible when performed by surgeons experienced in open procedures. Specific considerations are needed to safely introduce RPD.
方法:这是一项遵循IDEAL框架的前瞻性2a期研究。由两名具有开放手术专业知识的外科医生在一个中心进行的连续10例RPD被分配到研究中。客观评价,根据程序的成就,每例分为四个等级。在前一种情况下观察到的错误用于在下一种情况下通知程序。回顾了10例患者的手术效果。
结果:中位总手术时间为634分钟(四分位距[IQR],594-668),中位切除时间为363分钟(IQR,323-428)和123分钟的重建时间(IQR,107-131).整个程序的成就被评为A级,\"成功\",两个病人。在两个病人中,由于广泛的气腹,采用小型剖腹手术进行了重建,可能是由于插入了一个来自氧磷的肝脏牵开器。2例患者术后发生主要并发症。一个病人,其中空肠肢体通过Treitz韧带抬高,患有肠梗阻,需要再次剖腹手术。
结论:由在开放手术中有经验的外科医生进行RPD是可行的。需要具体考虑以安全地引入RPD。