The ACURE Trial: Acupuncture for Colorectal Recovery

N/ANot Yet RecruitingNCT07496528

Chang Gung Memorial Hospital240 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

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.

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. Participation in another clinical trial within the past 6 months. Anticipated inability to complete the study protocol due to physical, psychological, or logistical reasons.

Outcomes

Primary Outcomes

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.

Time frame: From the end of surgery up to postoperative day 30.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At Postoperative Day 3 and Postoperative Day 28.