Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial.

Abstract

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.

• Authors: Jian Wang, Dongli Li, Wei Tang, Jun Guo, Wenting Chen, Yue Yong, Wei Song, Guijie Yu, Rui Feng, Lan Yuan, Guoqiang Fu, Jiangang Song, Lihua Fan
• Journal: BMJ open (BMJ Open) Vol. 10 Issue 8 Pg. e030694 (08 20 2020) ISSN: 2044-6055 [Electronic] England
• PMID: 32819923 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 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.

Topics

• Acupuncture Points
• Adolescent
• Adult
• Aged
• Colon
• Humans
• Ileus (etiology, prevention & control)
• Laparoscopy
• Middle Aged
• Pain, Postoperative (prevention & control)
• Prospective Studies
• Randomized Controlled Trials as Topic
• Transcutaneous Electric Nerve Stimulation
• Treatment Outcome
• Young Adult