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.
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.
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.
Parallel
Electroacupuncture (EA)
DeviceA 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)
DeviceParticipants 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) Protocol
Procedure/SurgeryStandardized 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.
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.
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 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.
Length of Postoperative Hospital Stay
The duration (measured in days) from the completion of the surgical procedure to the time of hospital discharge.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
