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Colorectal CancerNCT06128785

Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery

A study testing Electroacupuncture group and Conventional Treatment group in people with Colorectal Cancer and Gastrointestinal Dysfunction, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to verify the efficacy of electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery. The main questions it aims to answer are: Whether electroacupuncture can accelerate the recovery of gastrointestinal function in patients after… Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Electroacupuncture group and Conventional Treatment group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
1 siteChina
Study dates
6 Nov 2023to 6 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Surgical patients who meet the diagnostic criteria for colorectal cancer and require elective radical colorectal cancer surgery;
  • 18 years old ≤ age ≤ 79 years old, with no restriction on gender;
  • Understand, agree to participate in this study and sign the informed consent form;
  • American society of Aneshesiologists (ASA) classification I to III.

Who cannot join

  • Patients with psychiatric disorders;
  • Patients who have participated or are participating in other clinical studies in the 3 months prior to enrollment;
  • Patients with severe malnutrition (NRS2002 score ≥ 3);
  • Patients with total colectomy;
  • Patients undergoing ileal diversion for rectal cancer;
  • Patients with tumor infiltration requiring resection of other organs;
  • Prophylactic fistulae. Anyone who meets any of the above criteria will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai Yueyang Integrated Medicine Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Electroacupuncture Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery: a Multicenter Randomized Controlled Study

The goal of this clinical trial is to verify the efficacy of electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery. The main questions it aims to answer are:

  • Whether electroacupuncture can accelerate the recovery of gastrointestinal function in patients after colorectal cancer surgery.
  • Whether electroacupuncture intervention is safe for postoperative colorectal cancer patients.
Read more

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated. From the patient's safe return to the ward until fourth day post-surgery, or until the occurrence of the first postoperative flatus, administer treatment every 12 ± 8 hours for 30 minutes per session.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad.

Read the detailed description

Colorectal cancer is the most common and predominant malignancy, and radical resection surgery, as the main method of current treatment for colon and gastrointestinal cancers, is performed on a large number of patients each year. Clinically, abdominal surgery causes the highest frequency of gastrointestinal dysfunction and the longest relative duration of dysfunction. A condition in which gastrointestinal function has not fully recovered after abdominal surgery is called gastrointestinal dysfunction. The common symptoms of postoperative gastrointestinal dysmotility are abdominal distension, abdominal pain, nausea and vomiting, diminished or even absent bowel sounds, loss of anal discharge, loss of bowel movements, and even secondary symptoms such as fever and pulmonary infection. It will adversely affect patients' postoperative quality of life to varying degrees, weaken their gastrointestinal barrier capacity, and severe gastrointestinal dysfunction can lead to complications such as electrolyte disorders, intestinal adhesions, intestinal obstruction, anastomotic fistula, and abdominal wall incision dehiscence in patients, as well as increase the social burden and the economic burden of patients. Some clinical reports show that acupuncture has good efficacy on gastrointestinal dysfunction, and acupuncture has effects on the gastrointestinal tract such as promoting gastrointestinal motility and reducing the inflammatory response of the gastrointestinal tract. In this study, a multicenter, randomized, blinded, sham acupuncture-controlled clinical design will be used to verify the efficacy of postoperative electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery.

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated. From the patient's safe return to the ward until fourth day post-surgery, or until the occurrence of the first postoperative flatus, administer treatment every 12 ± 8 hours for 30 minutes per session.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad. In other words, the electroacupuncture instrument show the state of being connected, but it is not actually energized; the acupuncture points, acupuncture time points, frequency, retention time and treatment duration were the same as those of the intervention group.

Being tested
Electroacupuncture group, Sham EA group, Conventional Treatment group
Keywords
Colorectal Cancer, Gastrointestinal Dysfunction, Enhanced Recovery After Surgery, Electroacupuncture, Randomized Controlled Trial
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture groupOther

    Also called experimental group

    Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min per session. From the patient's safe return to the ward until fourth day post-surgery, or until the occurrence of the first postoperative flatus, administer treatment every 12 ± 8 hours.

  • Sham EA groupOther

    Sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output.

  • Conventional Treatment groupOther

    Routine perioperative management for all patients referenced to Enhanced Recovery After Surgery components, including fuid resuscitation, nutritional support, correction of acid-base and electrolyte imbalances, infection control, and hemostasis.

Study groups in NCT06128785
Study groupRoleWhat they receive
Electroacupuncture groupExperimentalThe acupuncture will be performed within 6 hours after surgery Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min per session. From the patient's safe return to the ward until fourth day post-surgery, or until the occurrence of the first postoperative flatus, administer treatment every 12 ± 8 hours.
Receives: Other: Electroacupuncture group
Sham EA groupSham comparatorIn order to achieve maximum patient blindness, both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output. All study patients will be treated independently and separately to ensure that patients will not come into contact with each other.
Receives: Other: Sham EA group
Conventional treatment groupOtherRoutine perioperative management referenced to Enhanced Recovery After Surgery components, including postoperative fluid and nutritional support, correction of acid-base imbalance, electrolyte disorders, anti-infection, hemostasis and other symptomatic management.
Receives: Other: Conventional Treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of first postoperative exhaust

    The time between the patient's first exhaust and the end of surgery will be recorded.

    Measured: up to 4 days after surgery.

Secondary outcomes (11)
  1. Time of first postoperative defecation

    Patients self-report their defecation and doctors record the time.

    Measured: up to 4 days after surgery.

  2. Length of recovery of bowel sounds after surgery ( Yueyang Hospital records only)

    Monitoring by continuous auscultation recorder of bowel sounds immediately at the end of surgery; Determination of recovery of postoperative bowel sounds: Defined as the time interval between the end of surgery and the first postoperative occurrence of bowel sounds, calculate its time until the end of surgery (h). Only recorded at Yueyang Hospital. Immediately after surgery, continuous auscultation of bowel sounds will be performed using the continuous auscultation recorder (Model: YM-TYJL-01, Yimai Medical Technology Co., Ltd.).

    Measured: up to 4 days after surgery.

  3. Time of first postoperative intake of water

    The time when the patient first entered water after surgery was recorded separately.

    Measured: up to 4 days after surgery.

  4. Number of Postoperative nausea and vomiting episods

    During the postoperative hospitalization, whenever nausea, vomiting and abdominal distension occur, patients or their family members use the uniform tabulation to record the occurrence time by themselves and inform the medical staff in time, and the medical staff keep records at the same time. The time until the end of the operation and the number of postoperative episodes will be calculated before discharge.

    Measured: up to 4 days after surgery.

  5. Quality of life scale 1

    Version 3.0 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), standard score, range from 0 to 100, higher scores mean a better outcome.

    Measured: baseline, discharge 1 day, 1 month after surgery.

  6. Quality of life scale 2

    Short Form 12 scale (Chinese version). (Short Form 12 scale consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability).

    Measured: baseline, discharge 1 day, 1 month after surgery.

  7. Visual Analog Scale (VAS) of Pain

    Visual analogy score (0 to 5, higher scores mean a worse outcome)

    Measured: up to 4 days after surgery.

  8. Postoperative hospitalization days

    Calculate and record the number of days from the day of surgery to the day of patient discharge.

    Measured: up to 4 days

  9. Biochemical indexes 1

    Hypersensitive C-reactiveprotein (hs-CRP), μg/L.

    Measured: 1 hour postoperatively, 12 hours postoperatively, 72 hours postoperatively.

  10. Biochemical indexes 2

    Interleukin-6 (IL-6), μg/L.

    Measured: 1 hour postoperatively, 12 hours postoperatively, 72 hours postoperatively.

  11. Biochemical indexes 3

    serum albumin (ALB), g/L.

    Measured: baseline, discharge 1 day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start6 Nov 2023
  3. Primary completion8 Feb 2026
  4. Study completion6 Mar 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Needles: Huatuo brand disposable acupuncture needles φ0.25×40mm (1.5 inch); needles are purchased from Suzhou Medical Supplies Factory Co. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), lasting 30 min each time. Postoperative electroacupuncture stimulation method: all acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min per session. From the patient's safe return to the ward until fourth day post-surgery, or until the occurrence of the first postoperative flatus, administer treatment every 12 ± 8 hours.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128785
Sponsor's protocol ID
2023-144
Status last verified
Sep 2026
First submitted
4 Sep 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data that underlie results in a publication.

Publications

  • Sun L, Wei X, Feng T, Gu Q, Li J, Wang K, Zhou J. Electroacupuncture promotes gastrointestinal functional recovery after radical colorectal cancer surgery: a protocol of multicenter randomized controlled trial (CORRECT trial). Int J Colorectal Dis. 2024 Dec 9;39(1):198. doi: 10.1007/s00384-024-04768-8.

    PubMed 39652211

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture group and Conventional Treatment group in people with Colorectal Cancer and Gastrointestinal Dysfunction, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of first postoperative exhaust (time frame: up to 4 days after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06128785, which also lists 1 linked publication.

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 30 Sep 2026.

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