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肢体软组织肉瘤患者术前与术后放疗局部并发症的评估:一项随机对照临床试验。

Assessment of local complications with preoperative versus postoperative radiotherapy in patients with soft tissue sarcoma in extremities: A randomized comparative clinical trial.

作者信息

Abdallah Ziad Khaled, El Masry Ayman Mohammad, Azmy Sherif Ishak, El Mowafi Mohamed Ahmed, Rahman Mustafa Mohamed Abdel

机构信息

Orthopaedic Surgery, Ain Shams University, Egypt.

出版信息

J Orthop. 2024 Feb 28;53:34-40. doi: 10.1016/j.jor.2024.02.042. eCollection 2024 Jul.

Abstract

BACKGROUND

Radiotherapy is considered a cornerstone as adjuvant or neo adjuvant to surgery in extremity soft tissue sarcoma (ESTS). Wound complications are the most agonizing complication that may have an impact on patient's functional outcome following radiotherapy. The best care for ESTS is by combining extensive surgical excision with safety margin and radiotherapy either preoperative (neoadjuvant) or postoperative. Preoperative radiotherapy allows for lower dose of radiation over smaller fields which is supposed to decrease long-term complications. However, several studies have shown that early complications which include wound dehiscence, infection, seroma and burn may be more frequent with preoperative radiotherapy than with postoperative radiotherapy. Most of these studies were retrospective. This study aims to prospectively assess and compare the early complications associated with radiotherapy in both techniques.

HYPOTHESIS

Preoperative radiotherapy is not inferior to postoperative radiotherapy regarding early wound complications.

PATIENTS AND METHODS

Between January 2021 and June 2022, we prospectively studied 22 patients and categorized them into two groups, group A (preoperative radiotherapy) and group B (postoperative radiotherapy). We included patients with extremity soft tissue sarcoma in skeletally mature patients who were randomized into two groups with follow up 9-12 months. Wound complications, local complications, recurrence, time for wound healing and survival rate were recorded and analyzed using SPSS 25.

RESULTS

22 patients were included, 10 in group A and 12 in group B, their mean age was 46.4 years with mean follow up 9 months. The major wound complications were higher in group A (preoperative radiotherapy). in comparison with group B (postoperative radiotherapy), however, this was not statistically significant. While other local complications were higher in group B, it was also statistically insignificant. Time for wound healing was higher in group A more than group B and was statistically significant (p value = 0.011).

CONCLUSION

No increase in the wound complications rate with preoperative radiotherapy by using low fractionated doses of radiotherapy and increasing interval before surgery to six weeks, although there is increased risk of delayed wound healing time after surgery. The size and site of the tumor may increase the risk of wound complications unrelated to the type of radiotherapy.

LEVEL OF EVIDENCE

II: clinical trial.

摘要

背景

放射治疗被认为是肢体软组织肉瘤(ESTS)手术辅助或新辅助治疗的基石。伤口并发症是最令人痛苦的并发症,可能会影响放疗后患者的功能结局。ESTS的最佳治疗方法是将广泛的手术切除与安全切缘以及术前(新辅助)或术后放疗相结合。术前放疗允许在较小的照射野上使用较低剂量的辐射,这被认为可以减少长期并发症。然而,几项研究表明,与术后放疗相比,术前放疗的早期并发症(包括伤口裂开、感染、血清肿和烧伤)可能更常见。这些研究大多是回顾性的。本研究旨在前瞻性评估和比较两种技术中与放疗相关的早期并发症。

假设

在早期伤口并发症方面,术前放疗不劣于术后放疗。

患者和方法

在2021年1月至2022年6月期间,我们前瞻性研究了22例患者,并将他们分为两组,A组(术前放疗)和B组(术后放疗)。我们纳入了骨骼成熟的肢体软组织肉瘤患者,将其随机分为两组,随访9 - 12个月。使用SPSS 25记录并分析伤口并发症、局部并发症、复发、伤口愈合时间和生存率。

结果

纳入22例患者,A组10例,B组12例,平均年龄46.4岁,平均随访9个月。A组(术前放疗)的主要伤口并发症较高。然而,与B组(术后放疗)相比,这在统计学上并不显著。虽然B组的其他局部并发症较高,但在统计学上也不显著。A组的伤口愈合时间比B组更长,且具有统计学意义(p值 = 0.011)。

结论

通过使用低分割剂量放疗并将手术前间隔时间延长至六周,术前放疗不会增加伤口并发症发生率,尽管术后伤口愈合时间延迟的风险增加。肿瘤的大小和部位可能会增加与放疗类型无关的伤口并发症风险。

证据水平

II:临床试验。

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