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一项评估术前碳水化合物负荷对接受上皮性卵巢癌大手术的女性影响的单中心随机对照研究。

A Single Centre Randomised Control Study to Assess the Impact of Pre-Operative Carbohydrate Loading on Women Undergoing Major Surgery for Epithelial Ovarian Cancer.

作者信息

Al-Hirmizy Deniz, Wood Nicholas J, Ko Stanley, Henry Ann, Nugent David, West Robert, Duffy Sean

机构信息

Obstetrics and Gynaecology, Diana Princess of Wales Hospital, Grimsby, GBR.

Gynaecologic Oncology, Lancashire Teaching Hospital NHS Foundation Trust, Preston, GBR.

出版信息

Cureus. 2020 Aug 31;12(8):e10169. doi: 10.7759/cureus.10169.

Abstract

Objective Historically, patients have fasted before elective surgery to ensure an empty stomach to avoid aspiration. A fasting-induced catabolic state however may adversely influence recovery after surgery. Our study was designed to test the effect of oral carbohydrate loading on clinical parameters in patients undergoing major surgery for advanced-stage ovarian cancer. Methods A double-blinded single-centre randomised trial was designed to recruit 110 patients with advanced-stage epithelial ovarian cancer undergoing either primary surgery, or neoadjuvant chemotherapy prior to debulking surgery. Following written informed consent, the patients were randomised into two groups. Group 1 received the carbohydrate drink (intervention) and group 2 received flavoured water (placebo). The quantity of fluid in both groups was 800ml the night before the surgery and 400ml two hours before the induction of anaesthesia. The primary endpoint of the study was the Length of Hospital Stay (LoHS); the secondary parameters assessed were pain scores, nausea and vomiting scores, bowel function, and postoperative complication rate. Results Between March 2009 and December 2011, 80 patients were randomised and 75 completed the study. A decision was made to close the trial early as a change in routine clinical practice meant that patients were admitted on the day of surgery rather than a day before. Analysis of the data revealed that there were no significant differences between the study groups in terms of LoHS and other clinical parameters. Conclusion In this single-center study, which failed to recruit the planned number of patients, we were unable to demonstrate that oral carbohydrate intake pre-operatively has significant impact on the recovery process or the length of hospitalisation postoperatively. Future studies should examine all aspects of an Enhanced Recovery Program after Surgery as a package as compared to a single element to enhance patient outcome.

摘要

目的 从历史上看,患者在择期手术前需要禁食,以确保胃排空,避免误吸。然而,禁食引起的分解代谢状态可能会对术后恢复产生不利影响。我们的研究旨在测试口服碳水化合物负荷对晚期卵巢癌接受大手术患者临床参数的影响。方法 设计了一项双盲单中心随机试验,招募110例晚期上皮性卵巢癌患者,这些患者将接受初次手术或在肿瘤细胞减灭术前接受新辅助化疗。在获得书面知情同意后,将患者随机分为两组。第1组接受碳水化合物饮料(干预组),第2组接受调味水(安慰剂组)。两组在手术前一晚的液体摄入量均为800ml,麻醉诱导前两小时为400ml。该研究的主要终点是住院时间(LoHS);评估的次要参数包括疼痛评分、恶心和呕吐评分、肠道功能以及术后并发症发生率。结果 在2009年3月至2011年12月期间,80例患者被随机分组,75例完成了研究。由于常规临床实践的改变意味着患者在手术当天而非前一天入院,因此决定提前终止试验。数据分析显示,研究组之间在住院时间和其他临床参数方面没有显著差异。结论 在这项未能招募到计划数量患者的单中心研究中,我们无法证明术前口服碳水化合物摄入对恢复过程或术后住院时间有显著影响。未来的研究应该将术后强化康复计划的所有方面作为一个整体进行研究,而不是单一要素,以改善患者的预后。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c96/7526975/582094b698e1/cureus-0012-00000010169-i01.jpg

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