西部地区县级医院大隐静脉曲张微创术式学习曲线的前瞻性随机对照研究

A prospective randomized controlled study of the learning curve of minimally invasive varicose surgery in county-level hospitals in the western regions of China

目的比较外科治疗大隐静脉曲张的高位结扎抽剥术(high ligation and stripping,HLS)与腔内射频消融术(radio frequency ablation,RFA)在西部地区县级医院医师培训的效果及其学习曲线。方法选取2018年8月—2020年8月西吉县人民医院普通外科收治的具有外科治疗指征并同意接受治疗的100例单侧大隐静脉曲张患者的资料。采用随机数字表法将患者分为RFA组和HLS组,每组各50例。选择西吉县人民医院普通外科的1名无静脉曲张手术经验、未进行过血管彩色多普勒超声(彩超)操作的主治医师,接受海军军医大学第二附属医院(上海长征医院)血管外科专家组培训,当培训对象在专家组全程帮带下可独立主刀完成HLS和RFA手术各1例时,可参与本研究。将每组50例患者按照时间顺序划分为5个阶段(phase,P):P1(第1~10例)、P2(第11~20例)、P3(第21~30例)、P4(第31~40例)、P5(第41~50例)。P1+P2代表前期,P3代表中期,P4+P5代表后期。选择手术总时间和大隐静脉主干剥离/闭合时间作为主要观察指标。其他指标包括术前培训课时、术中出血量、切口数目、切口总长度(所有切口长度之和)、住院天数、住院费用及术后并发症发生情况。术后3个月门诊随访,观察患者是否存在隐神经损伤、残留曲张静脉,并行下肢血管彩超复查大隐静脉主干是否复通。结果HLS组和RFA组手术总时间和大隐静脉主干剥离/闭合时间的学习曲线均呈现明显下降趋势,RFA组较HLS组的下降程度更为明显。在全期(即P1至P5),HLS组的手术总时间与RFA组的差异无统计学意义(P=0.495),而大隐静脉主干剥离/闭合时间显著长于RFA组(P=0.028)。在前期,RFA组的手术总时间和大隐静脉主干剥离/闭合时间均显著长于HLS组(P值均<0.05);在中期,两组间两个时间的差异均无统计学意义(P值均>0.05);在后期,RFA组的手术总时间和大隐静脉主干剥离/闭合时间均显著短于HLS组(P值均<0.05)。RFA组需要额外进行血管超声的理论知识与操作课程的培训,故其总课时为12课时,多于HLS组的6课时。RFA组的术中出血量、切口数目均显著少于HLS组,且切口总长度、住院天数显著短于HLS组(P值均<0.05)。RFA组医保报销前、后的住院费用均显著多于HLS组(P值均<0.05)。在术后并发症方面,RFA组皮下瘀斑的发生率显著低于HLS组(P<0.05),两组隐神经损伤、残留曲张静脉的差异比均无统计学意义(P值均>0.05)。结论尽管RFA前期培训课时较长,但与HLS相比,其具备学习曲线较短、安全、简捷、有效且医疗费用低的优势,适宜在技术受限和经济条件相对落后的西部地区的县级医院开展与推广。

Objective To compare the training effect and learning curve of high ligation and stripping(HLS)and radio frequency ablation(RFA)for surgical treatment of great saphenous varicosis in county-level hospitals in western regions of China.Methods From August 2018 to August 2020,100 patients with unilateral varicosis of great saphenous vein were randomly divided into RFA group and HLS group(n=50).A surgeon without experience in varicose vein surgery from the Xiji County People’s Hospital,after receiving training and passing the assessment,performed the surgeries for all patients in the study.The patients in each group were divided into five phases in chronological order:P1(1 st to 10 th cases),P2(11 st to 20 th cases),P3(21 st to 30 th cases),P4(31 st to 40 th cases),and P5(41 st to 50 th cases).P1+P2 was considered as early period,P3 as medium period,and P4+P5 as later period.The total operation time and the great saphenous vein main stripping/closure time were used to evaluate the learning curve.The preoperative training hours,intraoperative blood loss,incision amount,total incision length,hospital stay,hospitalization costs,and postoperative complications were compared between groups.Outpatient follow-up was conducted 3 months after the operation to observe whether there was saphenous nerve injury and residual varicose vein,and vascular ultrasound of lower limbs was performed to check whether the main great saphenous vein was recanalized.Results The total operation time and the great saphenous vein main stripping/closure time showed a significant downward trend on the learning curve in both groups,and the decline in the RFA group was more obvious than that in the HLS group.In the whole period(P1-P5),there was no significant difference in the total operation time between groups(P=0.495),but the saphenous vein main stripping/closure time was significantly shorter in the RFA group than that in the HLS group(P=0.028).In the early period(P1+P2),the total operation time and the great saphenous vein main stripping/closure time in the RFA group were significantly longer than those in the HLS group(P<0.05).In the medium period(P3),there was no significant difference in the above-mentioned indexes between groups(P>0.05).In the later period(P4+P5),the total operation time and the great saphenous vein main stripping/closure time in the RFA group were significantly shorter than those in the HLS group(P<0.05).The RFA group needed training on the theoretical knowledge and operation of vascular ultrasound,so its total preoperative class hours were 12 hours,which was 6 hours more than in the HLS group.Intraoperative blood loss,incision amount,total incision length,and hospital stay in the RFA group were significantly less than those in the HLS group(all P<0.05).The hospitalization costs before and after medical insurance reimbursement in the RFA group were significantly higher than those in the HLS group(both P<0.05).In terms of postoperative complications,the incidence of subcutaneous ecchymosis in the RFA group was significantly lower than that in HLS group(P<0.05),and there were no significant difference in the incidence of saphenous nerve injury or residual varicose vein between two groups(both P>0.05).Conclusion Although it takes long time for the pre-training of RFA,compared with HLS,RFA is safe,simple,effective,affordable,and suitable for county-level hospitals in the western regions,where the technical level and economic conditions are relatively backward.