背景:对于静脉曲张患者,目标是缓解疼痛和肿胀,减轻水肿的严重程度,改善皮肤变化,和治愈与静脉疾病相关的溃疡。压缩疗法是他们管理的基石。多项研究表明,在第一个24小时内佩戴弹性绷带,然后再使用压缩长袜一周可以有效减轻热消融后的疼痛。然而,在临床实践中,患者对这种治疗的依从性可能会更好,考虑到拉起和拆除压缩袜的困难,松紧度,和皮肤刺激,因为这些必须长时间佩戴。对抗这些障碍的潜在解决方案是短期压缩疗法。此外,热消融后穿紧身袜的效果和必要性受到质疑。根据目前的临床经验和有限的证据,尽管一些学者认为,压缩治疗可能是热消融后不必要的辅助治疗,与压缩治疗相比,热消融后无压缩治疗仍存在很大的不确定性.因此,我们主张进一步研究评估术后短期加压治疗的临床效果。此外,需要精心设计的随机对照试验.
方法:前瞻性,多中心,非劣效性随机对照试验旨在评估3个月时目标静脉闭塞率的非劣效性.三百六十位患者将以1:1的比例随机分配到以下治疗之一:(A)3M™Coban™弹性绷带48小时或(B)3M™Coban™弹性绷带前24小时,然后进行II类压缩全长长袜(23-32mmHg)1周。两组将在几个变量上进行比较,包括3个月时的目标静脉闭塞率(主要结果指标),疼痛,生活质量,静脉曲张的临床严重程度,术后并发症,回到正常工作的时间,和合规。
结论:假设3M™Coban™弹性绷带48小时的效果证明不劣于长期压迫治疗。在这种情况下,这种短期治疗可能有助于未来更新热消融术后加压治疗的临床指南。导致更高的患者依从性和更好的术后生活质量。
背景:临床试验NCT05840991。2023年5月注册。
BACKGROUND: For patients with varicose veins, the goal is to relieve pain and swelling, reduce the severity of edema, improve skin changes, and heal ulcers associated with venous disease. Compression therapy is the cornerstone of their management. Several studies have shown that wearing an elastic bandage for the first 24 h and then a compression stocking for a week can effectively reduce the pain after thermal ablation. However, in clinical practice, patient compliance with this treatment could be better, considering difficulties in pulling up and removing the compression stocking, tightness, and skin irritation because these must be worn for a prolonged period. A potential solution to battling these barriers is short-term compression therapy. Besides, the effect and necessity of wearing compression stockings after thermal ablation have been questioned. Based on current clinical experience and limited evidence, although some scholars have suggested that compression therapy may be an unnecessary adjunctive therapy after thermal ablation, there is still a great deal of uncertainty in the absence of compression therapy after thermal ablation compared to compression therapy. Therefore, we advocate further research to evaluate the clinical effect of short-term postoperative compression therapy. Furthermore, well-designed randomized controlled trials are needed.
METHODS: A prospective, multicenter, non-inferiority randomized controlled trial is designed to evaluate the non-inferiority of target vein occlusion rate at 3 months. Three hundred and sixty patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) 3 M™ Coban™ elastic bandage for 48 h or (B) 3 M™ Coban™ elastic bandage for the first 24 h and then a class II compression full-length stocking (23-32 mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator), pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to regular work, and compliance.
CONCLUSIONS: Suppose the effect of the 3 M™ Coban™ elastic bandage for 48 h proves to be non-inferior to long-term compression therapy. In that case, this short-term treatment may contribute to a future update of clinical guidelines for compression therapy after thermal ablation of varicose veins, resulting in higher patient compliance and better postoperative quality of life.
BACKGROUND: Clinical Trials NCT05840991 . Registered on May 2023.