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术前电针对结直肠肿瘤腹腔镜手术后术后肠麻痹的疗效:一项多中心、随机、 sham 对照试验的研究方案。

Preoperative electroacupuncture versus sham electroacupuncture for the treatment of postoperative ileus after laparoscopic surgery for colorectal cancer in China: a study protocol for a multicentre, randomised, sham-controlled trial.

机构信息

International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.

Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, China.

出版信息

BMJ Open. 2024 Jul 5;14(7):e083460. doi: 10.1136/bmjopen-2023-083460.


DOI:10.1136/bmjopen-2023-083460
PMID:38969370
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11227784/
Abstract

INTRODUCTION: Postoperative ileus (POI) is a postoperative complication that can cause lingering recovery after colorectal resection and a heavy healthcare system burden. Acupuncture aims to prevent postoperative complications, reduce the duration of POI, help recovery and shorten hospital stays. We hypothesise that preoperative electroacupuncture (EA) can promote POI recovery under the enhanced recovery after surgery protocol after laparoscopic surgery in patients with POI. METHODS AND ANALYSIS: This is a multicentre, randomised, sham-controlled trial. A total of 80 patients will be enrolled and randomly assigned to the EA or sham electroacupuncture (SA) group. The eligible patients will receive EA or SA for one session per day with treatment frequency starting on preoperative day 1 for four consecutive days. The primary outcome is the time to first defecation. The secondary outcomes include the time to first flatus, length of postoperative hospital stay, time to tolerability of semiliquid and solid food, postoperative nausea, vomiting, pain and extent of abdominal distention, time to first ambulation, preoperative anxiety, 30-day readmission rate, the usage of anaesthetics and analgesics during operation, length of postanaesthesia care unit stay. A mechanistic study by single-cell RNA sequencing in which postintervention normal intestinal tissue samples will be collected. The results of this study will provide evidence of the effects of acupuncture on POI and promote good clinical decision to millions of patients globally every year. ETHICS AND DISSEMINATION: This study has been approved by the ethical application of Beijing University of Chinese Medicine (2022BZYLL0401), Beijing Friendship Hospital Affiliated to Capital Medical University(2022-P2-368-02), Cancer Hospital Chinese Academy of Medical Science (23/175-3917), Huanxing Cancer Hospital (2023-002-02). The results will be published in a medical journal. In addition, we plan to present them at scientific conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300077633.

摘要

简介:术后肠梗阻(POI)是一种术后并发症,可导致结直肠切除术后恢复时间延长,并给医疗保健系统带来沉重负担。针刺旨在预防术后并发症,缩短 POI 持续时间,促进恢复并缩短住院时间。我们假设在 POI 患者接受腹腔镜手术后的加速康复外科(ERAS)方案下,术前电针(EA)可以促进 POI 的恢复。

方法和分析:这是一项多中心、随机、 sham 对照试验。总共将纳入 80 名患者,并随机分配到 EA 或 sham 电针(SA)组。合格的患者将接受 EA 或 SA 治疗,每天一次,治疗频率从术前第 1 天开始,连续 4 天。主要结局是首次排便时间。次要结局包括首次排气时间、术后住院时间、耐受半流质和固体食物时间、术后恶心、呕吐、疼痛和腹胀程度、首次下床活动时间、术前焦虑、30 天再入院率、手术期间麻醉和镇痛药物的使用、麻醉后护理单元停留时间。通过单细胞 RNA 测序进行机制研究,其中将采集干预后正常肠组织样本。该研究的结果将为针刺治疗 POI 的效果提供证据,并每年为数百万全球患者做出良好的临床决策。

伦理和传播:该研究已获得北京中医药大学伦理申请批准(2022BZYLL0401)、首都医科大学附属北京友谊医院(2022-P2-368-02)、中国医学科学院肿瘤医院(23/175-3917)和环星癌症医院(2023-002-02)。结果将发表在医学期刊上。此外,我们计划在科学会议上展示这些结果。

试验注册号:ChiCTR2300077633。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/eab1f2de9584/bmjopen-2023-083460f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/eaac23c6b1ea/bmjopen-2023-083460f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/d8512a2474ef/bmjopen-2023-083460f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/eab1f2de9584/bmjopen-2023-083460f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/eaac23c6b1ea/bmjopen-2023-083460f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/d8512a2474ef/bmjopen-2023-083460f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba33/11227784/eab1f2de9584/bmjopen-2023-083460f03.jpg

相似文献

[1]
Preoperative electroacupuncture versus sham electroacupuncture for the treatment of postoperative ileus after laparoscopic surgery for colorectal cancer in China: a study protocol for a multicentre, randomised, sham-controlled trial.

BMJ Open. 2024-7-5

[2]
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BMJ Open. 2022-4-15

[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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本文引用的文献

[1]
Clinical practice guidelines for prevention and treatment of postoperative gastrointestinal disorder with Integrated Traditional Chinese and Western Medicine (2023).

J Evid Based Med. 2024-3

[2]
Global cost of postoperative ileus following abdominal surgery: meta-analysis.

BJS Open. 2023-5-5

[3]
Gum Chewing and Coffee Consumption but not Caffeine Intake Improve Bowel Function after Gastrointestinal Surgery: a Systematic Review and Network Meta-analysis.

J Gastrointest Surg. 2023-8

[4]
Electroacupuncture vs Sham Electroacupuncture in the Treatment of Postoperative Ileus After Laparoscopic Surgery for Colorectal Cancer: A Multicenter, Randomized Clinical Trial.

JAMA Surg. 2023-1-1

[5]
Effect of acupuncture on postoperative ileus after laparoscopic elective colorectal surgery: A prospective, randomised, controlled trial.

EClinicalMedicine. 2022-5-27

[6]
Electroacupuncture versus sham electroacupuncture in the treatment of postoperative ileus after laparoscopic surgery for colorectal cancer: study protocol for a multicentre, randomised, sham-controlled trial.

BMJ Open. 2022-4-15

[7]
Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies.

BMJ Open. 2021-9-6

[8]
Pain threshold, anxiety and other factors affect intensity of postoperative pain in gastric cancer patients: A prospective cohort study.

Chin J Cancer Res. 2021-6-30

[9]
Electroacupuncture ameliorates intestinal inflammation by activating α7nAChR-mediated JAK2/STAT3 signaling pathway in postoperative ileus.

Theranostics. 2021-2-19

[10]
Preoperative risk factors associated with chronic pain profiles following total knee arthroplasty.

Eur J Pain. 2021-3

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