Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer (CRC)
• Intervention / Treatment: Device: TEA; Device: sham-TEA

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Yu; Phone Number: 86006663; Email: xinxin_yu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir run run shaw Hospital
      • Contact: Xin Yu; Phone Number: 86006663; Email: xinxin_yu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEA	Device: 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 Comparator: sham-TEA	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged post operative ileus (PPOI)	defined as no flatus for more than 72 hours	Assessed up to 72 hours after surgery
time to first defecation	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	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	"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	"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	"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	The time from the end of the surgery to the first ambulation (hours).	Assessed up to 10 days after surgery
Postoperative nausea	The number and frequency of postoperative nausea episodes	At 24, 48, and 72 hours after surgery
postoperative vomiting	The number and frequency of postoperative vomiting	At 24, 48, and 72 hours after surgery
postoperative abdominal distension	The number and frequency of postoperative abdominal distension	At 24, 48, and 72 hours after surgery
Use of anti-emetic drugs after surgery	Number of participants using antiemetic drugs	At 24, 48, and 72 hours after surgery
Severity of postoperative pain	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	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	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	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	primary admission plus any readmission up to 30 days	Assessed up to 30 days after surgery
Unplanned readmission	Record the number of unplanned re-admissions within 30 days of hospital discharge	Assessed up to 30 days after surgery
Postoperative quality of recovery	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)

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20260413053418925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No