Balint I B, Vizsy L, Vargovics E, Farics A, Parti K, Simon E
Department of Surgery, Kanizsai Dorottya Hospital, Hospital of Nagykanizsa, Nagykanizsa, Hungary -
Int Angiol. 2014 Dec;33(6):547-52. Epub 2014 Mar 28.
The aim of the present study was to prove the effectiveness, reliability and minimal invasiveness of cryosclerosis.
A prospective non-randomized study had been performed. The study enrolled 96 patients; 48 patients were treated by cryosclerosis and the other 48 by conventional stripping. Every time high ligation and phlebectomy of varices were done, in 1 patient the incompentence of the small saphenous vein was treated also by cryosclerosis. During the follow-up visits the obliteration of the great saphenous saphenous vein (GSV) was investigated; as primary objective of the study, secondary outcome measures were the most frequent complications of the conventional surgery, postoperative pain and recovery. Color-Duplex scan of the operated lower extremity was performed into 30 patients of the study group. Additionally, the vein wall (unhandled and frozen) was analyzed by transmission electron microscope in one case. All of the involved patients were examined at a follow-up visit (7 days after surgery) and sent back a questionnaire (6-8 weeks after surgery).
Recanalization was observed only in 2 patients (success rate after 6 weeks: 93.3%). Thromboembolic events occurred only in the control group (1 patient, minor pulmonary embolism). Regarding mild wound healing disorder and lymphorrhea there were no significant differences between the groups. Concerning postoperative pain, bruising and recovery the cryosclerosis was found significantly favorable. The incidence of limb swelling after surgery was the same in each group. Temporary sensory abnormalities seem to be frequent in the study group, but the results show that the rate of permanent saphenous nerve injury is higher in the patients operated with the conventional method. The histological examination showed changes in the frozen vein wall.
Lacking long-term results, we can only consider that cryosclerosis allows the occlusion of the great saphenous vein, is minimal invasive and should be considered among endovenous procedures for treating GSV incompetence.
本研究旨在证明冷冻硬化疗法的有效性、可靠性及微创性。
进行了一项前瞻性非随机研究。该研究纳入96例患者；48例患者接受冷冻硬化治疗，另外48例接受传统剥脱术治疗。每次进行大隐静脉曲张高位结扎及静脉切除术时，1例患者的小隐静脉功能不全也采用冷冻硬化治疗。随访期间，对大隐静脉（GSV）的闭塞情况进行研究；作为研究的主要目标，次要结局指标为传统手术最常见的并发症、术后疼痛及恢复情况。对研究组的30例患者进行了手术下肢的彩色双功能超声扫描。此外，对1例患者的静脉壁（未处理和冷冻的）进行了透射电子显微镜分析。所有纳入患者均在术后7天进行随访检查，并在术后6 - 8周返回一份问卷。
仅2例患者观察到再通（6周后成功率：93.3%）。血栓栓塞事件仅发生在对照组（1例患者，轻微肺栓塞）。关于轻度伤口愈合障碍和淋巴漏，两组之间无显著差异。在术后疼痛、瘀斑和恢复方面，发现冷冻硬化疗法明显更具优势。每组术后肢体肿胀的发生率相同。研究组中临时感觉异常似乎较为常见，但结果显示，采用传统方法手术的患者大隐神经永久性损伤的发生率更高。组织学检查显示冷冻静脉壁有变化。
由于缺乏长期结果，我们只能认为冷冻硬化疗法可使大隐静脉闭塞，具有微创性，应被视为治疗GSV功能不全的腔内治疗方法之一。
