Efficacy and safety of long-term transcutaneous electroacupuncture versus sham transcutaneous electroacupuncture for delayed gastric emptying after distal gastrectomy: study protocol for a randomized, patient-assessor blinded, controlled trial.

Autor: Chen KB; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Wu ZW; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Wang J; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Zhu LH; Department of Gastrointestinal Surgery, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, No. 3 East Qing-Chun Road, Hangzhou, 310020, China., Jin XL; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Chen GF; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Kang MX; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Huang Y; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Zhang H; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Lin LL; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Shi DK; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Wu D; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Chen JF; Department of General Surgery, Shang-Yu branch of SAHZU, School of Medicine, No. 517 Shi-Min Road, Shaoxing, 312300, China., Chen J; Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China., Zhao ZQ; Department of General Surgery, Shang-Yu branch of SAHZU, School of Medicine, No. 517 Shi-Min Road, Shaoxing, 312300, China. 1599051443@qq.com.
Jazyk: angličtina
Zdroj: Trials [Trials] 2022 Mar 03; Vol. 23 (1), pp. 189. Date of Electronic Publication: 2022 Mar 03.
DOI: 10.1186/s13063-022-06108-z
Abstrakt: Background: Delayed gastric emptying (DGE) after distal gastrectomy impacts patients' nutritional status and quality of life. The current treatments of DGE seem unsatisfactory or need invasive interventions. It is unknown whether transcutaneous electroacupuncture (TEA) is effective in treating DGE.
Methods: A total of 90 eligible participants who underwent distal gastrectomy will be randomly allocated to either the TEA group (n = 60) or the sham transcutaneous electroacupuncture (sham-TEA) group (n = 30). Each participant will receive TEA on the bilateral acupoints of Zusanli (ST36) and Neiguan (PC6) for 4 weeks. The primary outcomes will be the residual rates of radioactivity in the stomach by gastric scintigraphy and total response rates. The secondary outcomes will be endoscopic features, autonomic function, nutritional and psychological status, serum examination, and quality of life (QoL). The adverse events will also be reported. The patients will be followed up 1 year after the treatment.
Discussion: The findings of this randomized trial will provide high-quality evidence regarding the efficacy and safety of long-term TEA for treating DGE after distal gastrectomy.
Trial Registration: Chinese Clinical Trial Registry ChiCTR2000033965. Registered on 20 June 2020.
(© 2022. The Author(s).)
Databáze: MEDLINE
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