Mohammadi Tofigh Arash, Tahmasebi Hamed, Zebarjadi Javad
Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Assistant Professor, Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Lasers Med Sci. 2020 Fall;11(Suppl 1):S43-S48. doi: 10.34172/jlms.2020.S7. Epub 2020 Dec 30.
Varicosis is a condition affecting the superficial venous system of the lower limbs. Endovenous laser ablation (EVLA) is a minimally invasive method that uses different frequencies of laser for treatment. Radiofrequency (RF) has also been effectively used for vein ablation through thermal mechanisms. This study compares the success rate and side effects of EVLA and RF to treat varicose veins in the lower limbs within 12 months. In this two-arm, parallel-group, randomized controlled, single-blind study, 1090 patients with lower limb varicosis proven by Doppler ultrasonography (DUS) were randomly placed into one of the two groups: EVLA and RF ablation. In the EVLA group, we used a 980-nm diode laser in a pulse mode and in the RF group, a 7-cm ClosureFast (Covidien, USA) catheter with an RF generator. We assessed pain during the operation and 8 and 24 hours after the surgery by the numerical rating scale (NRS). The patients were followed up on day 7, then 3, 6, and 12 months postoperatively. The presence or absence of pain and then the severity of pain (according to NRS), the recurrence rate, complications, and the length of the procedure were compared. There was no significant difference between the two groups in the patients' characteristics, major adverse events and pain severity during the procedure and 8 and 24 hours after the surgery. According to NRS, the mean chronic pain severity in the EVLA group was 3.99± 0.754 versus 4.50± 0.657 in the RF group, and the difference was not significant. The length of operation and the recurrence rate 12 months after the procedure were not significantly different. The results of our study further establish the efficacy of EVLT and RF ablation for lower limb varicosis treatment without any significant difference in the clinical outcomes and complications during a 12-months follow-up.
静脉曲张是一种影响下肢浅静脉系统的病症。静脉腔内激光消融术(EVLA)是一种微创方法,使用不同频率的激光进行治疗。射频(RF)也已通过热机制有效地用于静脉消融。本研究比较了EVLA和RF在12个月内治疗下肢静脉曲张的成功率和副作用。在这项双臂、平行组、随机对照、单盲研究中,1090例经多普勒超声检查(DUS)证实患有下肢静脉曲张的患者被随机分为两组之一:EVLA组和RF消融组。在EVLA组中,我们使用脉冲模式的980纳米二极管激光,在RF组中,使用带有射频发生器的7厘米ClosureFast(美国科惠医疗)导管。我们通过数字评分量表(NRS)评估手术期间以及术后8小时和24小时的疼痛情况。患者在术后第7天、然后在术后3个月、6个月和12个月进行随访。比较有无疼痛情况以及疼痛的严重程度(根据NRS)、复发率、并发症和手术时长。两组患者的特征、主要不良事件以及手术期间、术后8小时和24小时的疼痛严重程度无显著差异。根据NRS,EVLA组的平均慢性疼痛严重程度为3.99±0.754,而RF组为4.50±0.657,差异不显著。手术时长和术后12个月的复发率无显著差异。我们的研究结果进一步证实了EVLT和RF消融治疗下肢静脉曲张的疗效,在12个月的随访期间临床结果和并发症方面无任何显著差异。