The ACURE Trial: Acupuncture for Colorectal Recovery

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.

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.