Purpose: Patients undergoing head and neck cancer surgery after prior radiation or chemoradiation are at high risk for wound complications. Hypothyroidism is a known risk factor for wound complications, especially fistulae after salvage total laryngectomy. The purpose of this phase II clinical trial is to investigate the effect of peri-operative intravenous levothyroxine supplementation on wound complications in patients undergoing salvage total laryngectomy. Patients and Methods: Euthyroid patients previously treated with radiation/chemoradiation undergoing total laryngectomy were prospectively recruited (n=72). Post-operatively, intravenous levothyroxine was administered at a weight-based dose (1.3 mcg/kg/day) and transitioned to enteral dosing on day 7. Free T3, T4, and thyroid stimulating hormone (TSH) were collected and dosing was adjusted accordingly. The primary endpoints were rates of fistula and fistula requiring re-operation, compared to matched historical controls. All patients were monitored for adverse effects. Results: The rate of post-operative hypothyroidism was 21% compared to 49% in a matched historic cohort. The rate of fistula was 18.1% while the rate of fistula requiring re-operation was 4.2%, significantly lower than rates in our historic cohort (34.6% and 14.8% respectively, p=0.02 and 0.01). Post-operative hypothyroidism and recurrent clinical stage predicted fistula requiring re-operation in multivariate analysis; other acute phase reactants were not predictive. There were no observed adverse events related to levothyroxine supplementation. Conclusions: Post-operative intravenous levothyroxine supplementation reduced rates of acute hypothyroidism, fistula, and fistula requiring re-operation in patients undergoing salvage total laryngectomy without adverse effects. Intravenous levothyroxine is a viable strategy to reduce wound complications in this high-risk patient population.

中文翻译：

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静脉注射左旋甲状腺素减轻甲状腺功能正常患者行抢救性喉切除术的咽皮瘘的 II 期临床试验

目的：在既往放疗或放化疗后接受头颈癌手术的患者发生伤口并发症的风险很高。甲状腺功能减退症是伤口并发症的已知危险因素，尤其是挽救性全喉切除术后的瘘管。这项II期临床试验的目的是研究围手术期静脉补充左旋甲状腺素对挽救性全喉切除术患者伤口并发症的影响。患者和方法：前瞻性招募既往接受过放疗/放化疗并接受全喉切除术的甲状腺功能正常的患者（n=72）。术后，静脉注射左旋甲状腺素，剂量基于体重（1.3 mcg/kg/天），并在第 7 天转为肠内给药。收集游离 T3、T4 和促甲状腺激素 (TSH)，并相应调整剂量。主要终点是与匹配的历史对照相比，瘘管发生率和需要再次手术的瘘管发生率。监测所有患者的不良反应。结果：术后甲状腺功能减退症的发生率为 21%，而匹配的历史队列中的发生率为 49%。瘘管发生率为 18.1%，而需要再次手术的瘘管发生率为 4.2%，显着低于我们历史队列中的发生率（分别为 34.6% 和 14.8%，p=0.02 和 0.01）。多变量分析显示，术后甲状腺功能减退症和复发性临床分期预示着需要再次手术的瘘管；其他急性期反应物无法预测。没有观察到与补充左旋甲状腺素相关的不良事件。结论：术后静脉补充左旋甲状腺素可降低接受挽救性全喉切除术的患者急性甲状腺功能减退、瘘管和需要再次手术的瘘管发生率，且无副作用。静脉注射左旋甲状腺素是减少这一高危患者群体伤口并发症的可行策略。