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Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

14. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TEA
Enhed: 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).
Sham-komparator: sham-TEA
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Flatus
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prolonged post operative ileus (PPOI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sir Run Run Shaw Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20260413053418925

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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