Acupuncture for Colorectal sUrgery Recovery Enhancement: A Randomized Controlled Trial Evaluating Gastrointestinal Functional Recovery After Minimally Invasive Resection

NCT07496528 | Not Yet Recruiting

• 1 other identifier: 202501558A3
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Postoperative Complication; Colorectal Neoplasms; Ileus Postoperative; Gastrointestinal Motility

Keywords

electroacupuncture; acupuncture therapy; colorectal cancer; enhanced recovery after surgery; minimally invasive surgery; postoperative ileus

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery up to postoperative day 30.

Secondary Outcomes (4)

• I-FEED Score Assessment

  At 24 hours and 72 hours post-surgery.

• Time to First Postoperative Flatus

  From the end of surgery up to postoperative day 30.

• Length of Postoperative Hospital Stay

  Up to postoperative day 30.

• Quality of Life Assessment (EORTC QLQ-C30)

  At Postoperative Day 3 and Postoperative Day 28.

Study Arms (3)

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.

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

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.

Procedure: Enhanced Recovery After Surgery (ERAS) Protocol

Interventions

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.

Electroacupuncture (EA) Group

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.

Sham Electroacupuncture (SA) Group

Enhanced Recovery After Surgery (ERAS) Protocol PROCEDURE

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.

Electroacupuncture (EA) Group; Sham Electroacupuncture (SA) Group; Standard Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications

Interventions

Electroacupuncture; Enhanced Recovery After Surgery; Clinical Protocols

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Perioperative Care; Surgical Procedures, Operative; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03