Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
12 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
190
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Xin Yu
- Numéro de téléphone: 86006663
- E-mail: xinxin_yu@zju.edu.cn
Lieux d'étude
-
-
Shandong
-
Binzhou, Shandong, Chine
- Pas encore de recrutement
- Shandong Medical and Pharmaceutical University Hospital
-
Contact:
- Shuhui Zhang
- Numéro de téléphone: 18354017338
- E-mail: 3259998310@qq.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chine
- Recrutement
- Sir Run Run Shaw Hospital
-
Contact:
- Xin Yu
- Numéro de téléphone: 86006663
- E-mail: xinxin_yu@zju.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
|
Comparateur factice: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to First Flatus
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prolonged post operative ileus (PPOI)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 juin 2026
Achèvement primaire (Estimé)
30 avril 2027
Achèvement de l'étude (Estimé)
31 mai 2028
Dates d'inscription aux études
Première soumission
30 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
8 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20260413053418925
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .