Transcutaneous electrical acupoint stimulation combined with electroacupuncture for rapid recovery of patients after laparotomy for gastrointestinal surgery: a study protocol for a randomised controlled trial
| Autor: | Ning Li, Hao Li, Ying He, Lingyun Lu, Qian Wen, Hangqi Hu, Yaming Zhou, Xiaoting Wu |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | BMJ Open, Vol 11, Iss 11 (2021) |
| Druh dokumentu: | article |
| ISSN: | 2044-6055 10627472 |
| DOI: | 10.1136/bmjopen-2021-053309 |
| Popis: | Introduction Abdominal surgery is associated with common complications, including decreased or poor appetite, abdominal distension, abdominal pain caused by decreased or absent gastrointestinal motility, anal arrest with flatus and defecation, and nausea and vomiting resulting from the use of anaesthetics and opioid analgesics. These complications seriously affect postoperative recovery, prolong hospital stay and aggravate patient burden. This study aims to investigate for the first time the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with electroacupuncture (EA) therapy for rapid recovery after laparotomy for gastrointestinal surgery. There have been no clinical studies of this combination therapy.Methods and analysis This will be a prospective, single-centre, three-arm, randomised controlled trial. A total of 480 patients undergoing abdominal surgery will be stratified according to surgery type (ie, gastric or colorectal procedure) and randomised into three groups; namely, the EA, TEAS +EA and control groups. The control group will receive enhanced recovery after surgery (ERAS)-standardised perioperative management, including preoperative education, optimising the anaesthesia scheme, avoiding intraoperative hypothermia, restrictive fluid infusion and reducing surgical trauma. The EA group will receive EA stimulation at LI4, PC6, ST36, ST37 and ST39 based on the ERAS-standardised perioperative management. Moreover, the TEAS +EA group will receive ERAS-standardised perioperative management; EA stimulation at the LI4, PC6, ST36, ST37 and ST39; and TEAS stimulation at ST21 and SP15. The primary outcome will be the GI-2 (composite outcome of time to first defaecation and time to tolerance of a solid diet). Secondary outcomes will include the time of first passage of flatus, time to first defaecation, time to tolerance of a solid diet, time to first ambulation, hospital duration from operation to discharge, pain and nausea vomiting scores on the Visual Analogue Scale, medication use, incidence of postoperative complications and evaluation of treatment modality acceptability. All statistical analyses will be performed based on the intention-to-treat principle.Ethics and dissemination Ethics approval has been granted by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021; number 52). The results are expected to be published in peer-reviewed journals.Trial registration number ChiCTR2100045646. |
| Databáze: | Directory of Open Access Journals |
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