Colorectal NeoplasmsACURENCT07496528
The ACURE Trial: Acupuncture for Colorectal Recovery
A study testing Electroacupuncture (EA) and Enhanced Recovery After Surgery (ERAS) Protocol in people with Colorectal Neoplasms and Ileus Postoperative, run by Chang Gung Memorial Hospital.
Trial summary
Purpose: The goal of this clinical trial is to evaluate whether electroacupuncture (EA) can accelerate the recovery of bowel function in patients undergoing minimally invasive surgery for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Ileus Postoperative, Postoperative Complication
- What is being tested?
- Electroacupuncture (EA) and Enhanced Recovery After Surgery (ERAS) Protocol
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 May 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal cancer requiring scheduled curative-intent resection.
- Age between 18 and 79 years, inclusive.
- Ability to understand the study protocol and provide written informed consent.
- American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
Who cannot join
- Pregnant or breastfeeding women.
- History of major abdominal surgery within the past 4 weeks.
- Receipt of chemotherapy or radiotherapy within the past 6 months.
- History of organ transplantation with rejection episodes within the past 30 days.
- Presence of active infection (e.g., tuberculosis, sepsis, peritonitis).
- Positive for hepatitis B, hepatitis C, or HIV with an uncontrolled viral load.
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- Severe malnutrition, defined as a Nutritional Risk Screening (NRS 2002) score ≥ 3.
- History of total colectomy or requirement for ileorectal anastomosis.
- Requirement for multivisceral resection due to tumor invasion.
- Scheduled for prophylactic stoma creation.
- Moderate to severe cognitive impairment, epilepsy, or uncontrolled neurological disorders.
- Active psychiatric illness (e.g., bipolar disorder, schizophrenia) that may interfere with study compliance.
- Severe cardiopulmonary insufficiency (e.g., New York Heart Association [NYHA] class IV heart failure or requirement for long-term oxygen therapy).
- Presence of open wounds, skin infections, or known allergies at or near the designated acupuncture sites.
- History of adverse reactions to acupuncture, including syncope (fainting) or needle phobia.
- Participation in another clinical trial within the past 6 months.
- Anticipated inability to complete the study protocol due to physical, psychological, or logistical reasons.
About this study
Official title: Acupuncture for Colorectal sUrgery Recovery Enhancement: A Randomized Controlled Trial Evaluating Gastrointestinal Functional Recovery After Minimally Invasive Resection
Purpose:
The goal of this clinical trial is to evaluate whether electroacupuncture (EA) can accelerate the recovery of bowel function in patients undergoing minimally invasive surgery for colorectal cancer.
Read more
Main Questions to be Answered:
Does electroacupuncture reduce the time to the first bowel movement after surgery compared to standard care or a "sham" (placebo) treatment?
Can electroacupuncture improve overall gastrointestinal tolerance and reduce postoperative discomfort?
Study Design:
Participants will be randomly assigned to one of three groups:
Electroacupuncture Group: Receives active electrical stimulation at specific acupuncture points.
Sham Acupuncture Group: Receives superficial needling at non-treatment points with no electrical current to serve as a placebo.
Standard Care Group: Receives standard hospital recovery protocols (ERAS) without acupuncture.
All treatments will consist of four 30-minute sessions: one before surgery and three on the days following the procedure. Researchers will compare the three groups to see if the electroacupuncture group experiences a faster return of digestive function.
Read the detailed description
Postoperative ileus (a temporary stop in bowel motility) is a common challenge following major abdominal surgery. This study, the ACURE trial, is a prospective, multi-center, randomized controlled trial designed to investigate the efficacy of electroacupuncture as an adjunctive therapy within an Enhanced Recovery After Surgery (ERAS) framework.
Intervention Protocol:
The intervention involves bilateral stimulation of five specific acupoints (ST36, ST37, SP6, LI4, and PC6) known in Traditional Chinese Medicine to regulate gastrointestinal motility and alleviate nausea. The sessions are administered once daily starting the day before surgery through postoperative day 3.
Objectives:
Primary: To measure the time (in hours) from the end of surgery to the patient's first spontaneous defecation.
Secondary: To evaluate the time to first flatus, tolerance of oral intake, postoperative pain levels (VAS scores), total analgesic consumption, and the overall length of hospital stay.
The study aims to enroll 240 participants across multiple centers to ensure statistical power. By using a three-arm design (True EA vs. Sham EA vs. Control), the trial seeks to distinguish the specific therapeutic effects of acupuncture from potential placebo effects or standard recovery improvements.
- Conditions
- Colorectal Neoplasms, Ileus Postoperative, Postoperative Complication, Gastrointestinal Motility
- Being tested
- Electroacupuncture (EA), Sham Electroacupuncture (SA), Enhanced Recovery After Surgery (ERAS) Protocol
- Keywords
- electroacupuncture, acupuncture therapy, colorectal cancer, enhanced recovery after surgery, minimally invasive surgery, postoperative ileus
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)Device
A licensed practitioner will administer electroacupuncture at five bilateral acupoints: ST36 (Zusanli), ST37 (Shangjuxu), SP6 (Sanyinjiao), LI4 (Hegu), and PC6 (Neiguan). Sterile acupuncture needles will be inserted to a depth of 15-30 mm to elicit the "deqi" sensation. An electroacupuncture device will deliver a continuous wave at a frequency of 5 Hz, with intensity adjusted to individual tolerance. Each session lasts 30 minutes. A total of 4 sessions will be performed: one session the day before surgery and three sessions on postoperative days 1, 2, and 3.
Sham Electroacupuncture (SA)Device
Participants receive superficial needling (2-3 mm depth) at five non-acupoint locations, anatomically distinct from the true acupoints. To maintain blinding, visually identical needles and a sham electroacupuncture device will be used. While electrodes are attached to the needles, the internal wiring of the stimulator is disconnected, ensuring no electrical current is delivered. The treatment timing (30 minutes per session) and overall schedule (4 sessions total) are identical to the Electroacupuncture group.
Enhanced Recovery After Surgery (ERAS) ProtocolProcedure or surgery
Standardized perioperative care including patient education, preoperative mechanical bowel preparation with oral antibiotics, minimally invasive surgical approach (laparoscopic or robotic), restrictive fluid management, early removal of nasogastric tube and urinary catheter, multimodal analgesia, and early postoperative mobilization and oral intake.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) Group | Experimental | Participants receive active electroacupuncture at bilateral acupoints ST36, ST37, SP6, LI4, and PC6. A continuous wave frequency of 5 Hz is applied for 30 minutes. Treatment occurs once daily: one session on preoperative day 1 and three sessions on postoperative days 1 to 3. Receives: Device: Electroacupuncture (EA); Procedure: Enhanced Recovery After Surgery (ERAS) Protocol |
| Sham Electroacupuncture (SA) Group | Sham comparator | Participants receive superficial needling (2-3 mm depth) at five non-acupoint locations. Electrodes are attached to a disconnected electroacupuncture device (no current delivered). The treatment schedule and duration (30 mins) are identical to the EA group Receives: Device: Sham Electroacupuncture (SA); Procedure: Enhanced Recovery After Surgery (ERAS) Protocol |
| Standard Care Group | Placebo comparator | Participants receive perioperative care according to the standard modified Enhanced Recovery After Surgery (ERAS) protocol without any acupuncture intervention. Receives: Procedure: Enhanced Recovery After Surgery (ERAS) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Postoperative Defecation
The time interval (measured in hours) from the completion of surgery to the first spontaneous passage of stool. Patients will record the exact time in the ACURE Trial Patient Diary.
Measured: From the end of surgery up to postoperative day 30.
Secondary outcomes (4)
I-FEED Score Assessment
The I-FEED (Intake, Feeling, Emesis, Exam, and Distention) scoring system will be used to evaluate gastrointestinal recovery. The total score ranges from 0 to 15, where higher scores indicate more severe gastrointestinal dysfunction or ileus.
Measured: At 24 hours and 72 hours post-surgery.
Time to First Postoperative Flatus
The time interval (measured in hours) from the completion of surgery to the first passage of anal gas, as reported by the patient in the study diary.
Measured: From the end of surgery up to postoperative day 30.
Length of Postoperative Hospital Stay
The duration (measured in days) from the completion of the surgical procedure to the time of hospital discharge.
Measured: Up to postoperative day 30.
Quality of Life Assessment (EORTC QLQ-C30)
Description: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30. It includes functional scales, symptom scales, and a global health status. Scores are transformed to a 0-100 scale; higher scores for functional scales represent better functioning, while higher scores for symptoms represent more severe symptoms.
Measured: At Postoperative Day 3 and Postoperative Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496528
- Sponsor's protocol ID
- 202501558A3
- Acronym
- ACURE
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Colorectal sUrgery Recovery Enhancement: A Randomized Controlled Trial Evaluating Gastrointestinal Functional Recovery After Minimally Invasive Resection
- ClinicalTrials.gov ID
- NCT07496528
- Acronym / sponsor ID
- ACURE / 202501558A3
- Conditions
- Colorectal Neoplasms, Ileus Postoperative, Postoperative Complication, Gastrointestinal Motility
- Keywords
- electroacupuncture, acupuncture therapy, colorectal cancer, enhanced recovery after surgery, minimally invasive surgery, postoperative ileus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 27 Mar 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.
Purpose:
The goal of this clinical trial is to evaluate whether electroacupuncture (EA) can accelerate the recovery of bowel function in patients undergoing minimally invasive surgery for colorectal cancer.
Main Questions to be Answered:
Does electroacupuncture reduce the time to the first bowel movement after surgery compared to standard care or a "sham" (placebo) treatment?
Can electroacupuncture improve overall gastrointestinal tolerance and reduce postoperative discomfort?
Study Design:
Participants will be randomly assigned to one of three groups:
Electroacupuncture Group: Receives active electrical stimulation at specific acupuncture points.
Sham Acupuncture Group: Receives superficial needling at non-treatment points with no electrical current to serve as a placebo.
Standard Care Group: Receives standard hospital recovery protocols (ERAS) without acupuncture.
All treatments will consist of four 30-minute sessions: one before surgery and three on the days following the procedure. Researchers will compare the three groups to see if the electroacupuncture group experiences a faster return of digestive function.
Detailed description
Postoperative ileus (a temporary stop in bowel motility) is a common challenge following major abdominal surgery. This study, the ACURE trial, is a prospective, multi-center, randomized controlled trial designed to investigate the efficacy of electroacupuncture as an adjunctive therapy within an Enhanced Recovery After Surgery (ERAS) framework.
Intervention Protocol:
The intervention involves bilateral stimulation of five specific acupoints (ST36, ST37, SP6, LI4, and PC6) known in Traditional Chinese Medicine to regulate gastrointestinal motility and alleviate nausea. The sessions are administered once daily starting the day before surgery through postoperative day 3.
Objectives:
Primary: To measure the time (in hours) from the end of surgery to the patient's first spontaneous defecation.
Secondary: To evaluate the time to first flatus, tolerance of oral intake, postoperative pain levels (VAS scores), total analgesic consumption, and the overall length of hospital stay.
The study aims to enroll 240 participants across multiple centers to ensure statistical power. By using a three-arm design (True EA vs. Sham EA vs. Control), the trial seeks to distinguish the specific therapeutic effects of acupuncture from potential placebo effects or standard recovery improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) Group | Experimental | Device: Electroacupuncture (EA), Procedure: Enhanced Recovery After Surgery (ERAS) ProtocolParticipants receive active electroacupuncture at bilateral acupoints ST36, ST37, SP6, LI4, and PC6. A continuous wave frequency of 5 Hz is applied for 30 minutes. Treatment occurs once daily: one session on preoperative day 1 and three sessions on postoperative days 1 to 3. |
| Sham Electroacupuncture (SA) Group | Sham comparator | Device: Sham Electroacupuncture (SA), Procedure: Enhanced Recovery After Surgery (ERAS) ProtocolParticipants receive superficial needling (2-3 mm depth) at five non-acupoint locations. Electrodes are attached to a disconnected electroacupuncture device (no current delivered). The treatment schedule and duration (30 mins) are identical to the EA group |
| Standard Care Group | Placebo comparator | Procedure: Enhanced Recovery After Surgery (ERAS) ProtocolParticipants receive perioperative care according to the standard modified Enhanced Recovery After Surgery (ERAS) protocol without any acupuncture intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed colorectal cancer requiring scheduled curative-intent resection.
- Age between 18 and 79 years, inclusive.
- Ability to understand the study protocol and provide written informed consent.
- American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
Key exclusion criteria (17 listed)
- Pregnant or breastfeeding women.
- History of major abdominal surgery within the past 4 weeks.
- Receipt of chemotherapy or radiotherapy within the past 6 months.
- History of organ transplantation with rejection episodes within the past 30 days.
- Presence of active infection (e.g., tuberculosis, sepsis, peritonitis).
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 |
|---|---|---|
| Electroacupuncture (EA)A licensed practitioner will administer electroacupuncture at five bilateral acupoints: ST36 (Zusanli), ST37 (Shangjuxu), SP6 (Sanyinjiao), LI4 (Hegu), and PC6 (Neiguan). Sterile acupuncture needles will be inserted to a depth of 15-30 mm to elicit the "deqi" sensation. An electroacupuncture device will deliver a continuous wave at a frequency of 5 Hz, with intensity adjusted to individual tolerance. Each session lasts 30 minutes. A total of 4 sessions will be performed: one session the day before surgery and three sessions on postoperative days 1, 2, and 3. | Device | Electroacupuncture (EA) Group |
| Sham Electroacupuncture (SA)Participants receive superficial needling (2-3 mm depth) at five non-acupoint locations, anatomically distinct from the true acupoints. To maintain blinding, visually identical needles and a sham electroacupuncture device will be used. While electrodes are attached to the needles, the internal wiring of the stimulator is disconnected, ensuring no electrical current is delivered. The treatment timing (30 minutes per session) and overall schedule (4 sessions total) are identical to the Electroacupuncture group. | Device | Sham Electroacupuncture (SA) Group |
| Enhanced Recovery After Surgery (ERAS) ProtocolStandardized perioperative care including patient education, preoperative mechanical bowel preparation with oral antibiotics, minimally invasive surgical approach (laparoscopic or robotic), restrictive fluid management, early removal of nasogastric tube and urinary catheter, multimodal analgesia, and early postoperative mobilization and oral intake. | Procedure or surgery | Electroacupuncture (EA) Group, Sham Electroacupuncture (SA) Group, Standard Care Group |
Primary outcome
Time to First Postoperative Defecation
Time frame: From the end of surgery up to postoperative day 30.
The time interval (measured in hours) from the completion of surgery to the first spontaneous passage of stool. Patients will record the exact time in the ACURE Trial Patient Diary.
4 secondary outcomes
I-FEED Score Assessment
Time frame: At 24 hours and 72 hours post-surgery.
Time to First Postoperative Flatus
Time frame: From the end of surgery up to postoperative day 30.
Length of Postoperative Hospital Stay
Time frame: Up to postoperative day 30.
Quality of Life Assessment (EORTC QLQ-C30)
Time frame: At Postoperative Day 3 and Postoperative Day 28.
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 6 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) and Enhanced Recovery After Surgery (ERAS) Protocol in people with Colorectal Neoplasms and Ileus Postoperative, run by Chang Gung Memorial Hospital.
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 17 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: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 to First Postoperative Defecation (time frame: From the end of surgery up to postoperative day 30.). 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 6 Apr 2026.