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Electro-acupuncture for gastrointestinal dysfunction after colorectal cancer surgery: A protocol for three-arm randomized controlled trial

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机构: [1]Chengdu Univ Tradit Chinese Med, Sch Acu Mox & Tuina, 37 Shi Er Qiao Rd, Chengdu 610075, Peoples R China [2]Sichuan Canc Hosp & Inst, 55,Sect 4,South Renmin Rd, Chengdu 610041, Peoples R China [3]Chongqing Hosp Tradit Chinese Med, 6 Panxiqizhi Rd, Chongqing 400021, Peoples R China [4]Chengdu Second Peoples Hosp, 10 South Qingyun St, Chengdu 610021, Peoples R China [5]Deyang Peoples Hosp, 173 North Taishan Rd, Deyang 618099, Peoples R China [6]Hosp Chengdu Univ Tradit Chinese Med, 39 Shi Er Qiao Rd, Chengdu 610075, Peoples R China
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关键词: Colorectal cancer Electro-acupuncture Postoperative gastrointestinal dysfunction Protocol Randomized controlled trial

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Introduction: Postoperative gastrointestinal dysfunction (POGD) is one of the most common complications after colorectal cancer (CRC) surgery and seriously affects the prognosis of patients. Furthermore, current clinical treatment measures have controversial efficacy or strong side effects. Electro-acupuncture (EA) is a safe therapeutic modality for POGD; however, high-quality evidence is scarce at present. This study will aim to evaluate the efficacy and safety of EA for POGD in patients with CRC.Methods: A total of 270 patients with POGD after CRC surgery will be recruited from five hospitals in China and assigned to EA, sham electro-acupuncture (SA), and routine treatment (RT) groups in a 1:1:1 ratio. Patients in the RT group will receive treatment based on enhanced recovery after surgery (ERAS), health education, and routine care. Patients in the EA and SA groups will be treated with EA or SA on the basis of RT, respectively, from postoperative days one to three, once per day. Follow-up will be performed at seven and fourteen days after surgery. The primary outcome is the time to the first postoperative passing flatus. Secondary outcomes include the following: time of first postoperative bowel movement, postoperative bowel sound recovery time, gastro-intestinal symptom rating scale, I-FEED (intake, feeling nauseated, emesis, physical exam, duration of symptoms) scale, postoperative surgical site pain degree, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30 (V3.0)), EORTC Quality of Life Questionnaire -Colorectal Cancer 29 (EORTC QLQ-CR29), postoperative complications, adverse acupuncture events, etc.Discussion: This study design is rigorous, and a scientific placebo acupuncture method is used. The advantages are (1) multi-center, prospective, large sample randomized control with strict quality control; (2) the placebo control method can minimize the true acupuncture effect on the basis of blinding patients as much as possible; (3) the gastrointestinal function and quality of life of POGD patients after passing flatus and defecation will be analyzed. Conclusion: The findings of the 3-arm clinical trial will demonstrate whether EA is effective and safe for patients with POGD after CRC surgery.Trial registration: ChiCTR2200062275 (registered on 31-07-2022).

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大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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出版当年[2023]版:
Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
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Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

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第一作者机构: [1]Chengdu Univ Tradit Chinese Med, Sch Acu Mox & Tuina, 37 Shi Er Qiao Rd, Chengdu 610075, Peoples R China
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