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Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

14 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

190

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Zhejiang
      • Hangzhou, Zhejiang, Cina
        • Sir Run Run Shaw Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comparatore fittizio: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Flatus
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prolonged post operative ileus (PPOI)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sir Run Run Shaw Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20260413053418925

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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