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针刺治疗对结直肠癌术后胃肠功能障碍的影响:随机对照试验的研究方案。

Effects of acupuncture treatment on postoperative gastrointestinal dysfunction in colorectal cancer: study protocol for randomized controlled trials.

机构信息

Beijing University of Chinese Medicine, Beijing, China.

Department of Colorectal Surgery, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.

出版信息

Trials. 2022 Jan 31;23(1):100. doi: 10.1186/s13063-022-06003-7.

Abstract

BACKGROUND

Postoperative gastrointestinal dysfunction (PGID) is a common complication arising from colorectal cancer surgery. Attributing factors, such as anesthesia, surgical retraction, and early intake of water, can inhibit gastrointestinal motility, causing constipation, reduction or absence of bowel sounds, nausea, vomiting, and other symptoms. Delayed recovery in gastrointestinal function can lead to intestinal obstructions or paralysis, anastomotic leaks, and other complications, affecting the patient's recovery and quality of life negatively. Due to its complex pathophysiology, treatment for PGID in colorectal patients has remained a challenge. Acupuncture is an alternative therapy commonly used for postoperative recovery. This study aims to evaluate the therapeutic efficacy and safety of acupuncture on PGID. Through the complementation of acupuncture and enhanced recovery after surgery (ERAS) protocols, the advantages of acupuncture treatments could be demonstrated to promote its application in future clinical practice.

METHODS

The study design is a prospective randomized controlled trial (RCT). One hundred sixty postoperative colorectal cancer patients will be recruited from Cancer Hospital Chinese Academy of Medical Sciences (CICAMS). Subjects who fulfill inclusion criteria will be randomly assigned into the acupuncture group (AG) (n = 80) or control group (CG) (n = 80). AG will receive acupuncture treatment and perioperative care guided by ERAS protocols, and CG will only receive perioperative care guided by ERAS protocols. The intervention will begin on the first day post-surgery, continuing for 4 days, with a follow-up assessment in a month. Time of first postoperative flatus would be the primary outcome measure. Secondary outcome measures include the time of first postoperative defecation, time of first fluid intake, time of first ambulation, postoperative hospital stay, gastrointestinal reaction score, acupuncture sensation evaluation scale, laboratory tests, postoperative quality of life, readmission rate, and postoperative complications. All results are evaluated from baseline, post-treatment, and upon follow-up.

DISCUSSION

The results of the study would help elucidate evidence of the therapeutic effects of acupuncture on the recovery of postoperative gastrointestinal function. The objective of the study aims for the eventual inclusion of acupuncture in the ERAS protocol, allowing for wider application in clinical practice.

TRIAL REGISTRATION

ClinicalTrials.gov ChiCTR2000036351. Registered on August 22, 2020.

摘要

背景

术后胃肠功能障碍(PGID)是结直肠癌手术后常见的并发症。麻醉、手术牵拉、早期饮水等因素可抑制胃肠蠕动,导致便秘、肠鸣音减少或消失、恶心、呕吐等症状。胃肠功能恢复延迟可导致肠粘连或麻痹、吻合口漏等并发症,对患者的恢复和生活质量产生负面影响。由于其复杂的病理生理学机制,结直肠患者 PGID 的治疗一直是一个挑战。针刺是一种常用于术后恢复的替代疗法。本研究旨在评估针刺治疗 PGID 的疗效和安全性。通过针刺与加速康复外科(ERAS)方案的互补,展示针刺治疗的优势,促进其在未来临床实践中的应用。

方法

研究设计为前瞻性随机对照试验(RCT)。将从中国医学科学院肿瘤医院招募 160 例结直肠癌术后患者。符合纳入标准的受试者将被随机分配到针刺组(AG)(n=80)或对照组(CG)(n=80)。AG 将接受针刺治疗和 ERAS 方案指导的围手术期护理,CG 将仅接受 ERAS 方案指导的围手术期护理。干预将从手术后第一天开始,持续 4 天,一个月后进行随访评估。首次术后排气时间为主要观察指标。次要观察指标包括首次术后排便时间、首次饮水时间、首次下床活动时间、术后住院时间、胃肠反应评分、针刺感觉评价量表、实验室检查、术后生活质量、再入院率和术后并发症。所有结果均在基线、治疗后和随访时进行评估。

讨论

该研究结果将有助于阐明针刺对术后胃肠功能恢复的治疗效果证据。该研究的目的是最终将针刺纳入 ERAS 方案,以便更广泛地应用于临床实践。

试验注册

ClinicalTrials.gov ChiCTR2000036351。注册于 2020 年 8 月 22 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8995/8805425/5cc4d1ee9a16/13063_2022_6003_Fig1_HTML.jpg

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