Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
12 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
190
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xin Yu
- Número de teléfono: 86006663
- Correo electrónico: xinxin_yu@zju.edu.cn
Ubicaciones de estudio
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Shandong
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Binzhou, Shandong, Porcelana
- Aún no reclutando
- Shandong Medical and Pharmaceutical University Hospital
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Contacto:
- Shuhui Zhang
- Número de teléfono: 18354017338
- Correo electrónico: 3259998310@qq.com
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Reclutamiento
- Sir Run Run Shaw Hospital
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Contacto:
- Xin Yu
- Número de teléfono: 86006663
- Correo electrónico: xinxin_yu@zju.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TEA
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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).
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Comparador falso: sham-TEA
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to First Flatus
Periodo de tiempo: Assessed up to 10 days after surgery
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Defined as the period from the end of the surgery to the time of first flatus (hours).
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Assessed up to 10 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prolonged post operative ileus (PPOI)
Periodo de tiempo: Assessed up to 72 hours after surgery
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defined as no flatus for more than 72 hours
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Assessed up to 72 hours after surgery
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time to first defecation
Periodo de tiempo: Assessed up to 10 days after surgery
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Defined as the period from the end of the surgery to the time of first defecation (hours).
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Assessed up to 10 days after surgery
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time to first water intake
Periodo de tiempo: Assessed up to 10 days after surgery
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The time from the end of the surgery to the first water intake (hours)
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Assessed up to 10 days after surgery
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Time to tolerance of liquid diet
Periodo de tiempo: Assessed up to 10 days after surgery
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"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.
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Assessed up to 10 days after surgery
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Time to tolerance of semi-liquid diet
Periodo de tiempo: Assessed up to 10 days after surgery
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"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.
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Assessed up to 10 days after surgery
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Time to tolerance of solid food
Periodo de tiempo: Assessed up to 10 days after surgery
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"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.
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Assessed up to 10 days after surgery
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Time to first ambulation
Periodo de tiempo: Assessed up to 10 days after surgery
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The time from the end of the surgery to the first ambulation (hours).
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Assessed up to 10 days after surgery
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Postoperative nausea
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative nausea episodes
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At 24, 48, and 72 hours after surgery
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postoperative vomiting
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative vomiting
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At 24, 48, and 72 hours after surgery
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postoperative abdominal distension
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative abdominal distension
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At 24, 48, and 72 hours after surgery
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Use of anti-emetic drugs after surgery
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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Number of participants using antiemetic drugs
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At 24, 48, and 72 hours after surgery
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Severity of postoperative pain
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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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).
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At 24, 48, and 72 hours after surgery
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Use of opioids drugs after surgery
Periodo de tiempo: At 24, 48, and 72 hours after surgery
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The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents.
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At 24, 48, and 72 hours after surgery
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TEA Security
Periodo de tiempo: Assessed up to 3 days after surgery
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assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
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Assessed up to 3 days after surgery
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Postoperative complications
Periodo de tiempo: From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
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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.
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From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
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Total length of hospital stay
Periodo de tiempo: Assessed up to 30 days after surgery
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primary admission plus any readmission up to 30 days
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Assessed up to 30 days after surgery
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Unplanned readmission
Periodo de tiempo: Assessed up to 30 days after surgery
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Record the number of unplanned re-admissions within 30 days of hospital discharge
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Assessed up to 30 days after surgery
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Postoperative quality of recovery
Periodo de tiempo: baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
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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.
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baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de junio de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
31 de mayo de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20260413053418925
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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