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

评估四肢软组织肉瘤患者术前与术后放疗的局部并发症:一项随机对照临床试验

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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.

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