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Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

12 de agosto de 2026 atualizado por: Xin Yu, Sir Run Run Shaw Hospital

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

190

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Shandong
      • Binzhou, Shandong, China
        • Ainda não está recrutando
        • Shandong Medical and Pharmaceutical University Hospital
        • Contato:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recrutamento
        • Sir Run Run Shaw Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: TEA
Dispositivo: 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 that the subject could tolerate). The stimulation parameters for ST36 were set as follows: 2 seconds of opening stimulation, 3 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude ranging from 2 to 10 mA (based on the maximum level that the subject could tolerate).
Comparador Falso: sham-TEA
Dispositivo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to First Flatus
Prazo: Assessed up to 10 days after surgery
Defined as the period from the end of the surgery to the time of first flatus (hours).
Assessed up to 10 days after surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Prolonged post operative ileus (PPOI)
Prazo: Assessed up to 72 hours after surgery
defined as no flatus for more than 72 hours
Assessed up to 72 hours after surgery
time to first defecation
Prazo: Assessed up to 10 days after surgery
Defined as the period from the end of the surgery to the time of first defecation (hours).
Assessed up to 10 days after surgery
time to first water intake
Prazo: Assessed up to 10 days after surgery
The time from the end of the surgery to the first water intake (hours)
Assessed up to 10 days after surgery
Time to tolerance of liquid diet
Prazo: Assessed up to 10 days after surgery
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after the liquid diet. Record the time (in hours) from the end of the surgery to the first tolerance to the liquid diet.
Assessed up to 10 days after surgery
Time to tolerance of semi-liquid diet
Prazo: Assessed up to 10 days after surgery
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after semi-liquid food. Record the time ( hours) from the end of the surgery to the first tolerance of semi-liquid food.
Assessed up to 10 days after surgery
Time to tolerance of solid food
Prazo: Assessed up to 10 days after surgery
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after solid food. Record the time (hours) from the end of the surgery to the first tolerance of solid food.
Assessed up to 10 days after surgery
Time to first ambulation
Prazo: Assessed up to 10 days after surgery
The time from the end of the surgery to the first ambulation (hours).
Assessed up to 10 days after surgery
Postoperative nausea
Prazo: At 24, 48, and 72 hours after surgery
The number and frequency of postoperative nausea episodes
At 24, 48, and 72 hours after surgery
postoperative vomiting
Prazo: At 24, 48, and 72 hours after surgery
The number and frequency of postoperative vomiting
At 24, 48, and 72 hours after surgery
postoperative abdominal distension
Prazo: At 24, 48, and 72 hours after surgery
The number and frequency of postoperative abdominal distension
At 24, 48, and 72 hours after surgery
Use of anti-emetic drugs after surgery
Prazo: At 24, 48, and 72 hours after surgery
Number of participants using antiemetic drugs
At 24, 48, and 72 hours after surgery
Severity of postoperative pain
Prazo: At 24, 48, and 72 hours after surgery
The assessment was conducted using a numerical rating scale (NRS). The scoring range was 0-10 (0 indicated no pain, while 10 indicated unbearable severe pain. Scores of 1-3 indicated mild pain that could be tolerated; 4-6 indicated pain that affected sleep but was still tolerable; 7-10 indicated severe pain that affected appetite and sleep).
At 24, 48, and 72 hours after surgery
Use of opioids drugs after surgery
Prazo: At 24, 48, and 72 hours after surgery
The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents.
At 24, 48, and 72 hours after surgery
TEA Security
Prazo: Assessed up to 3 days after surgery
assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
Assessed up to 3 days after surgery
Postoperative complications
Prazo: From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
The severity of complications was evaluated using the Clavien-Dindo classification system (grades I to V), with Clavien-Dindo grade ≥ III complications serving as the major surgical complications.
From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
Total length of hospital stay
Prazo: Assessed up to 30 days after surgery
primary admission plus any readmission up to 30 days
Assessed up to 30 days after surgery
Unplanned readmission
Prazo: Assessed up to 30 days after surgery
Record the number of unplanned re-admissions within 30 days of hospital discharge
Assessed up to 30 days after surgery
Postoperative quality of recovery
Prazo: baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
Assessed using the Quality of Recovery - 15 score (QoR-15) questionnaire preoperatively and daily. The total score ranges from 0 to 150 points. The higher the score, the better the post-anesthesia recovery quality.
baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sir Run Run Shaw Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

14 de junho de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

31 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de abril de 2026

Primeira postagem (Real)

8 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20260413053418925

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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