Electroacupuncture promotes gastrointestinal functional recovery after radical colorectal cancer surgery: a protocol of multicenter randomized controlled trial (CORRECT trial)

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Abstract
Introduction The incidence of postoperative gastrointestinal dysfunction (POGD) is notably high among patients following colorectal cancer surgery, highlighting the urgency for the prompt development of efficacious preventive and therapeutic approaches. Electroacupuncture (EA) represents an intervention modality that holds promise for the management of POGD. However, the existing empirical evidence substantiating its efficacy remains scarce. The aim of this study is to evaluate the efficacy and safety of EA as a treatment for POGD in patients undergoing colorectal cancer surgery. Methods This study is a multicenter, parallel-group, randomized controlled trial, named as CORRECT. CORRECT trial will recruit 300 participants diagnosed with colorectal cancer and about to undergo radical surgery across four sub-centers. The participants will be randomly assigned to one of three groups: the EA group, sham-electroacupuncture group, or control group, with a randomization ratio of 2:2:1. All groups will follow a standardized Enhanced Recovery After Surgery (ERAS) protocol. The EA group will receive EA at acupoints LI4, SJ6, ST36, and ST37, while the SA group will undergo sham-electroacupuncture. The treatments will be administered twice daily from the day of surgery until the fourth day after the operation. The primary endpoint is the time to first flatus, while secondary endpoints encompass time to first defecation, bowel sound emergence, initial water intake, duration of postoperative hospitalization, nausea and vomiting, pain levels, and blinded evaluations. Additional outcomes include medication usage and complication rates, et al. Discussion The CORRECT trial aims to provide high-quality evidence for the role of EA in the treatment of POGD following colorectal cancer surgery. It will contribute data towards the integration of acupuncture into ERAS protocols. Insights from the trial could help in tailoring treatment plans based on individual patient responses to EA, optimizing care on a case-by-case basis. Trial registration Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on November 2023 with the ClinicalTrials.gov Identifier: NCT06128785. URL: https://clinicaltrials.gov/study/NCT06128785?tab=history&a=1#study-details-card.
Funding Information
  • Program for Training Excellent Doctoral Students in Key Areas (GJ2023019)
  • Science and Technology Commission of Shanghai Municipality (21Y31920100, 21Y31920100)
  • Shanghai Clinical Research Center for Acupuncture and Moxibustion (20MC1920500, 20MC1920500)
  • Shanghai Shenkang Hospital Development Center (SHDC2022CRS040, SHDC2022CRS040)
  • Training Program for High-caliber Talents of Clinical Research at Affiliated Hospitals of SHUTCM (2023LCRC12, 2023LCRC12)
  • National Natural Science Fund of China (82104988)
  • Key construction discipline of National Administration of Traditional Chinese Medicine (ZYYZDXK-2023068)

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