The NEAT Study (Novel ElectroAcupuncture) - Electroacupuncture After Laparoscopic Colon Cancer Resection: Thinking Outside The Box. Study Protocol.

C. Vigna, María-Paz Orellana, Ingrid Sanchez, Natanael Pietroski, R. F. Vieira, Rinaldy Radhames Capellan, Nesiya Hassan, Roberto Rodríguez-Rivas, N. Mohammed, Almudena Fernández-Bravo, C. P. Ordonez, Maiara Cristina de Cesaro, Andy Silva-Santisteban
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Abstract

Introduction: Colorectal cancer is the second leading cause of cancer-related death in the US; complete surgical resection is the only curative treatment for non-metastatic colorectal cancer (NMCC). Postoperative ileus (POI) frequently increases patient morbidity and healthcare costs. Enhanced recovery after surgery (ERAS) protocol is the standard of care in most institutions and has been shown to reduce postoperative complications, but there is no a completely effective treatment for this condition. Studies suggest that electroacupuncture (EA) can improve gastrointestinal tract function after surgery. Objective: We aim to determine if including EA in the standard treatment of POI decreases the time to the first defecation, enhancing the return of normal bowel function after colon resection for NMCC. Methods: We propose a phase II, single-center, randomized, triple-blinded, sham-controlled trial with two parallel arms and a 1:1 allocation ratio. Patients 40-80 years of age diagnosed with NMCC scheduled to undergo laparoscopic surgery for colon cancer resection will be included. The arms will be EA + standard treatment and sham EA + standard treatment. The standard treatment will follow the ERAS protocol. Discussion: This will be the first randomized clinical trial to evaluate the impact of using EA along with the ERAS protocol for POI. This intervention may reduce patient morbidity and improve healthcare costs associated with the disease.
NEAT研究(新型电针)-腹腔镜结肠癌切除术后的电针:打破常规思考。研究协议。
导读:结直肠癌是美国癌症相关死亡的第二大原因;完全手术切除是治疗非转移性结直肠癌(NMCC)的唯一方法。术后肠梗阻(POI)经常增加患者的发病率和医疗费用。增强术后恢复(ERAS)方案是大多数机构的标准护理,已被证明可以减少术后并发症,但对于这种情况没有完全有效的治疗方法。研究表明,电针(EA)可以改善术后胃肠道功能。目的:我们的目的是确定将EA纳入POI的标准治疗是否减少了首次排便的时间,促进了NMCC结肠切除术后正常肠功能的恢复。方法:我们提出了一项II期、单中心、随机、三盲、假对照试验,采用两个平行臂,分配比例为1:1。40-80岁诊断为NMCC并计划行腹腔镜结肠癌切除术的患者将包括在内。实验组分为EA +标准治疗组和假EA +标准治疗组。标准治疗将遵循ERAS方案。讨论:这将是第一个随机临床试验,以评估使用EA和ERAS方案对POI的影响。这种干预可以降低患者的发病率,并改善与疾病相关的医疗保健费用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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