Kaiser Karsten, Valsamidis Alexandros Nikolaou, Karstensen Sven Hoedt, Strøm Thomas, Gögenur Ismail, Balsevicius Lukas, Lauszus Finn Friis
Department of Gynecology and Obstetrics, Aabenraa Hospital, Sygehus Sonderjylland, Denmark.
Department of Surgery, Aabenraa Hospital, Sygehus Sonderjylland, Denmark.
Contemp Clin Trials Commun. 2023 Mar 11;33:101109. doi: 10.1016/j.conctc.2023.101109. eCollection 2023 Jun.
Robotic-assisted hysterectomy is an alternative to laparoscopic surgery as part of a minimal invasive regimen. Several treatment strategies are followed to improve the overall outcome and minimize surgical stress. Glucocorticoids provide significant analgesic and antiemetic effects but their role in reducing inflammatory stress in a fast-track, multi-modal setting in patients undergoing minimally invasive surgery remains to be investigated in details.
This study will evaluate in a randomized trial the effect of a single dose of 24 mg dexamethasone on 100 women undergoing robotic-assisted hysterectomy with regard to surgical stress, measured by c-reactive protein as primary outcome and, further, other stress markers like white blood cell subtypes. The postoperative recovery will be registered in validated charts and questionnaires for pain and analgesic use, quality of recovery, incontinence, sexual and work life. Furthermore, in a sub-analysis, transcriptional profiling will be performed to explore the mechanism of systemic innate and adaptive immune system perturbation induced by surgical stress.
The study will provide solid evidence on markers of immunomodulation biomarkers and in addition the subjective effects and underlying mechanisms of perioperative glucocorticoid in women undergoing robotic hysterectomy. These include important aspects of life quality like pain, fatigue, freedom of medications, resuming work and sexual activities.
机器人辅助子宫切除术是作为微创治疗方案一部分的腹腔镜手术的替代方法。人们采用了几种治疗策略来改善总体疗效并将手术应激降至最低。糖皮质激素具有显著的镇痛和止吐作用,但其在快速康复、多模式治疗环境中对接受微创手术患者减轻炎症应激方面的作用仍有待详细研究。
本研究将在一项随机试验中评估单剂量24毫克地塞米松对100例行机器人辅助子宫切除术的女性在手术应激方面的影响,以C反应蛋白作为主要结局指标来衡量手术应激,此外还包括其他应激标志物,如白细胞亚型。术后恢复情况将通过经过验证的图表以及关于疼痛和镇痛药物使用、恢复质量、尿失禁、性生活和工作生活的问卷进行记录。此外,在一项亚分析中,将进行转录谱分析以探究手术应激诱导的全身固有和适应性免疫系统扰动的机制。
该研究将为免疫调节生物标志物以及围手术期糖皮质激素对行机器人子宫切除术女性的主观影响和潜在机制提供确凿证据。这些包括生活质量的重要方面,如疼痛、疲劳、药物使用自由度、恢复工作和性活动。