NCT07496528

The ACURE Trial: Acupuncture for Colorectal Recovery

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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	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.
PROCEDURE	Enhanced Recovery After Surgery (ERAS) Protocol	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-31
• Completion: 2029-05-31
• First posted: 2026-03-27
• Last updated: 2026-04-06