Colorectal Cancer (CRC)NCT07574502
Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
A study testing TEA in people with Colorectal Cancer (CRC), run by Sir Run Run Shaw Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- TEA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jun 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong
Shuhui Zhang, 18354017338, 3259998310@qq.com
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Xin Yu, 86006663, xinxin_yu@zju.edu.cn
About this study
Official title: 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.
Read more
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)
- Being tested
- TEA, sham-TEA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEADevice
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-TEADevice
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
| Study group | Role | What they receive |
|---|---|---|
| TEA | Experimental | Not described Receives: Device: TEA |
| sham-TEA | Sham comparator | Not described Receives: Device: sham-TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Flatus
Defined as the period from the end of the surgery to the time of first flatus (hours).
Measured: Assessed up to 10 days after surgery
Secondary outcomes (18)
Prolonged post operative ileus (PPOI)
defined as no flatus for more than 72 hours
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed up to 10 days after surgery
Time to first ambulation
The time from the end of the surgery to the first ambulation (hours).
Measured: Assessed up to 10 days after surgery
Postoperative nausea
The number and frequency of postoperative nausea episodes
Measured: At 24, 48, and 72 hours after surgery
postoperative vomiting
The number and frequency of postoperative vomiting
Measured: At 24, 48, and 72 hours after surgery
postoperative abdominal distension
The number and frequency of postoperative abdominal distension
Measured: At 24, 48, and 72 hours after surgery
Use of anti-emetic drugs after surgery
Number of participants using antiemetic drugs
Measured: 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).
Measured: 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.
Measured: At 24, 48, and 72 hours 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.
Measured: baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
TEA Security
assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
Measured: 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.
Measured: 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
Measured: Assessed up to 30 days after surgery
Unplanned readmission
Record the number of unplanned re-admissions within 30 days of hospital discharge
Measured: Assessed up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start14 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Yu, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574502
- Sponsor's protocol ID
- 20260413053418925
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT07574502
- Acronym / sponsor ID
- 20260413053418925
- Conditions
- Colorectal Cancer (CRC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 14 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEA | Experimental | Device: TEA |
| sham-TEA | Sham comparator | Device: sham-TEA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAThe 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). | Device | TEA |
| sham-TEASham-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 | Device | sham-TEA |
Primary outcome
Time to First Flatus
Time frame: Assessed up to 10 days after surgery
Defined as the period from the end of the surgery to the time of first flatus (hours).
18 secondary outcomes
Prolonged post operative ileus (PPOI)
Time frame: Assessed up to 72 hours after surgery
time to first defecation
Time frame: Assessed up to 10 days after surgery
time to first water intake
Time frame: Assessed up to 10 days after surgery
Time to tolerance of liquid diet
Time frame: Assessed up to 10 days after surgery
Time to tolerance of semi-liquid diet
Time frame: Assessed up to 10 days after surgery
Time to tolerance of solid food
Time frame: Assessed up to 10 days after surgery
Time to first ambulation
Time frame: Assessed up to 10 days after surgery
Postoperative nausea
Time frame: At 24, 48, and 72 hours after surgery
postoperative vomiting
Time frame: At 24, 48, and 72 hours after surgery
postoperative abdominal distension
Time frame: At 24, 48, and 72 hours after surgery
Use of anti-emetic drugs after surgery
Time frame: At 24, 48, and 72 hours after surgery
Severity of postoperative pain
Time frame: At 24, 48, and 72 hours after surgery
Use of opioids drugs after surgery
Time frame: At 24, 48, and 72 hours after surgery
Postoperative quality of recovery
Time frame: baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
TEA Security
Time frame: Assessed up to 3 days after surgery
Postoperative complications
Time frame: 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
Time frame: Assessed up to 30 days after surgery
Unplanned readmission
Time frame: Assessed up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEA in people with Colorectal Cancer (CRC), run by Sir Run Run Shaw Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yu (86006663, xinxin_yu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Flatus (time frame: Assessed up to 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.