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电针对胃肠癌腹腔镜术后胃肠功能恢复的临床研究——一项随机对照试验的研究方案。

Clinical study of electroacupuncture on the recovery of gastrointestinal dysfunction after laparoscopic surgery for gastrointestinal cancer - study protocol for a randomized controlled trial.

机构信息

Department of Acupuncture, Moxibustion and Tuina, Shanghai Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Medicine. No 358, Da Tong Road, Gaoqiao Town, Pudong New District, Shanghai, 200137, China.

Department of Gastrointestinal Surgery, Shanghai Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

BMC Complement Med Ther. 2024 Mar 12;24(1):119. doi: 10.1186/s12906-024-04418-0.

Abstract

BACKGROUND

Gastrointestinal dysfunction is one of the common complaints for patient post-surgery. Acupuncture has been employed to improve gastrointestinal function and sleeping quality and has confirmed clinical efficacy for emotional problems. This study aims to evaluate the clinical effect of electroacupuncture for postoperative rapid recovery.

METHODS

This study design is a two-arm, parallel, double-blinded randomized controlled trial. 104 subjects, aged from 40 to 89 years old, diagnosed with gastrointestinal cancer undergoing laparoscopic surgery, will be divided into Interventional Group and Control Group. Patients of both groups receive perioperative care under the guidance of ERAS guidance. The Interventional Group receives electroacupuncture treatment starting from the first day post-surgery for a consecutive 5 days, whereas the Control Group receives placebo electroacupuncture treatment. The primary outcome will be the first flatus time whereas the secondary outcomes will be the first sign of borborygmus, recovery of defecation, laboratory tests and questionnaires including Self-rating anxiety scale, Ford Insomnia Response to Stress Test, TCM rating scale of Gastrointestinal symptoms and Gastrointestinal Symptoms Rating Scales.

DISCUSSION

This study aims to provide timely intervention for post-laparoscopic patients with gastrointestinal tumour using the ERAS concept combined with electroacupuncture, observe the efficacy of this therapy in treating PGID, and contribute reliable scientific evidence for postoperative rapid recovery.

TRIAL REGISTRATION

Chictr.org.cn Identifier: ChiCTR2300078710. Registered on 15th December 2023.

摘要

背景

胃肠道功能障碍是术后患者常见的主诉之一。针刺已被用于改善胃肠道功能和睡眠质量,并已证实对情绪问题具有临床疗效。本研究旨在评估电针对术后快速康复的临床效果。

方法

本研究设计为双臂、平行、双盲随机对照试验。将 104 名年龄在 40 至 89 岁之间、被诊断为胃肠道癌症并接受腹腔镜手术的患者分为干预组和对照组。两组患者均在加速康复外科(ERAS)指导下接受围手术期护理。干预组从术后第一天开始接受连续 5 天的电针治疗,而对照组则接受安慰剂电针治疗。主要结局将是首次排气时间,次要结局将是首次肠鸣音、排便恢复、实验室检查和问卷,包括焦虑自评量表、福特失眠应激反应测试、中医胃肠症状评分和胃肠症状评分量表。

讨论

本研究旨在利用 ERAS 理念结合电针对腹腔镜胃肠肿瘤术后患者进行及时干预,观察该疗法治疗 PGID 的疗效,为术后快速康复提供可靠的科学依据。

试验注册

ChiCTR2300078710. 于 2023 年 12 月 15 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3890/10935837/41011dc922b7/12906_2024_4418_Fig1_HTML.jpg

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