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Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial
INTRODUCTION: Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment wit...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440825/ https://www.ncbi.nlm.nih.gov/pubmed/32819923 http://dx.doi.org/10.1136/bmjopen-2019-030694 |
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author | Wang, Jian Li, Dongli Tang, Wei Guo, Jun Chen, Wenting Yong, Yue Song, Wei Yu, Guijie Feng, Rui Yuan, Lan Fu, Guoqiang Song, Jiangang Fan, Lihua |
author_facet | Wang, Jian Li, Dongli Tang, Wei Guo, Jun Chen, Wenting Yong, Yue Song, Wei Yu, Guijie Feng, Rui Yuan, Lan Fu, Guoqiang Song, Jiangang Fan, Lihua |
author_sort | Wang, Jian |
collection | PubMed |
description | INTRODUCTION: Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI. METHODS AND ANALYSIS: This will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I–III level patients, aged 18–75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures. ETHICS AND DISSEMINATION: This study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: This study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184). TRIAL STATUS: The study was in the recruitment phase at the time of manuscript submission. |
format | Online Article Text |
id | pubmed-7440825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-74408252020-08-28 Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial Wang, Jian Li, Dongli Tang, Wei Guo, Jun Chen, Wenting Yong, Yue Song, Wei Yu, Guijie Feng, Rui Yuan, Lan Fu, Guoqiang Song, Jiangang Fan, Lihua BMJ Open Complementary Medicine INTRODUCTION: Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI. METHODS AND ANALYSIS: This will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I–III level patients, aged 18–75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures. ETHICS AND DISSEMINATION: This study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: This study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184). TRIAL STATUS: The study was in the recruitment phase at the time of manuscript submission. BMJ Publishing Group 2020-08-20 /pmc/articles/PMC7440825/ /pubmed/32819923 http://dx.doi.org/10.1136/bmjopen-2019-030694 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Complementary Medicine Wang, Jian Li, Dongli Tang, Wei Guo, Jun Chen, Wenting Yong, Yue Song, Wei Yu, Guijie Feng, Rui Yuan, Lan Fu, Guoqiang Song, Jiangang Fan, Lihua Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title | Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title_full | Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title_fullStr | Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title_full_unstemmed | Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title_short | Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
title_sort | pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial |
topic | Complementary Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440825/ https://www.ncbi.nlm.nih.gov/pubmed/32819923 http://dx.doi.org/10.1136/bmjopen-2019-030694 |
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