Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

Официальное название

Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol

Обзор

The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are: Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery. Participants will: Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days. Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.

Вмешательства

• Устройство TEA
  The subjects in the TEA group were placed in the supine position and received transcutaneous electrical acupoint stimulation at the bilateral PC6 and bilateral ST36 . After confirming the location of the acupoints , special skin treatment was carried out. The stimulation parameters for PC6 were set as follows: 0.1 seconds of opening stimulation, 0.4 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 100 Hz, and amplitude ranging from 1 to 10 mA (based on the maximum level
• Устройство sham-TEA
  Sham-TEA was the same except that non-acupoints were used to replace ST36 and PC6. The sham-acupoint for PC6 was located at about 15-20 cm away from PC6 (up to the elbow and outside of the coastal margin of the forearm not on any meridian) and the sham-point for ST36 was located at 10-15 cm down from and to the lateral side of ST36 not on any meridian

Первичные конечные точки

• Time to First Flatus [Срок оценки: Assessed up to 10 days after surgery]

Вторичные конечные точки (12)

• Prolonged post operative ileus (PPOI) [Срок оценки: Assessed up to 72 hours after surgery]
• time to first defecation [Срок оценки: Assessed up to 10 days after surgery]
• time to first water intake [Срок оценки: Assessed up to 10 days after surgery]
• Time to tolerance of liquid diet [Срок оценки: Assessed up to 10 days after surgery]
• Time to tolerance of semi-liquid diet [Срок оценки: Assessed up to 10 days after surgery]
• Time to tolerance of solid food [Срок оценки: Assessed up to 10 days after surgery]
• Time to first ambulation [Срок оценки: Assessed up to 10 days after surgery]
• Postoperative nausea [Срок оценки: At 24, 48, and 72 hours after surgery]
• postoperative vomiting [Срок оценки: At 24, 48, and 72 hours after surgery]
• postoperative abdominal distension [Срок оценки: At 24, 48, and 72 hours after surgery]
• Use of anti-emetic drugs after surgery [Срок оценки: At 24, 48, and 72 hours after surgery]
• Severity of postoperative pain [Срок оценки: At 24, 48, and 72 hours after surgery]

Критерии участия

Критерии включения

• Age ≥ 65 years old.
• Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.
• American Society of Anesthesiologists classification (ASA) 1-4.
• Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.
• The patient voluntarily participates in this study and signs the informed consent form.

Критерии исключения

• Previous history of abdominal gastrointestinal surgery.
• Planned for palliative or emergency surgery.
• Planned for open abdominal surgery or creation of a new stoma.
• Transfer to ICU.
• Diagnosed with severe heart, liver, kidney or mental system diseases.
• Patients with implanted cardiac pacemakers.
• Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.
• Planned to use epidural anesthesia or epidural analgesia.
• Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes/adhesive materials.
• Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month.
• Other conditions that the investigator considers make the patient unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sir Run Run Shaw Hospital — Ханчжоу

Идентификаторы

NCT: NCT07574502 · 20260413053418925

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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