Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

NCT07574502 | Not Yet Recruiting

• 1 other identifier: 20260413053418925
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• Time to First Flatus

  Defined as the period from the end of the surgery to the time of first flatus (hours).

  Assessed up to 10 days after surgery

Secondary Outcomes (18)

• Prolonged post operative ileus (PPOI)

  Assessed up to 72 hours after surgery

• time to first defecation

  Assessed up to 10 days after surgery

• time to first water intake

  Assessed up to 10 days after surgery

• Time to tolerance of liquid diet

  Assessed up to 10 days after surgery

• Time to tolerance of semi-liquid diet

  Assessed up to 10 days after surgery

Study Arms (2)

TEA

EXPERIMENTAL

Device: TEA

sham-TEA

SHAM COMPARATOR

Device: sham-TEA

Interventions

TEA DEVICE

The subjects in the TEA group were placed in the supine position and received electro-acupuncture treatment simultaneously at the bilateral PC6 and bilateral ST36 acupoints . 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).

TEA

sham-TEA DEVICE

Sham-TEA is similar to the real stimulation, but it uses non-acupoints instead of ST36 and PC6. The virtual acupoint of PC6 is located approximately 15 cm to 20 cm away from the PC6 (about 15 cm to 20 cm from the inner wrist，on the outer side of the forearm rib margin，not on any meridian)，and the virtual acupoint of ST36 is located 10 cm to 15 cm below ST36 and slightly to the outside，also not on any meridian.

sham-TEA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xin Yu

CONTACT

86006663; xinxin_yu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)