Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
12 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
190
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xin Yu
- Telefonnummer: 86006663
- E-post: xinxin_yu@zju.edu.cn
Studieorter
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Shandong
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Binzhou, Shandong, Kina
- Har inte rekryterat ännu
- Shandong Medical and Pharmaceutical University Hospital
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Kontakt:
- Shuhui Zhang
- Telefonnummer: 18354017338
- E-post: 3259998310@qq.com
-
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Rekrytering
- Sir Run Run Shaw Hospital
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Kontakt:
- Xin Yu
- Telefonnummer: 86006663
- E-post: xinxin_yu@zju.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Sham Comparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to First Flatus
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Prolonged post operative ileus (PPOI)
Tidsram: 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
Tidsram: 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
Tidsram: Assessed up to 10 days after surgery
|
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
Tidsram: 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
Tidsram: 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
|
|
Time to tolerance of solid food
Tidsram: 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
Tidsram: Assessed up to 10 days after surgery
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The time from the end of the surgery to the first ambulation (hours).
|
Assessed up to 10 days after surgery
|
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Postoperative nausea
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 juni 2026
Primärt slutförande (Beräknad)
30 april 2027
Avslutad studie (Beräknad)
31 maj 2028
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
8 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260413053418925
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