Acupuncture for Colorectal sUrgery Recovery Enhancement: A Randomized Controlled Trial Evaluating Gastrointestinal Functional Recovery After Minimally Invasive Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Time to First Postoperative Defecation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Sham Electroacupuncture (SA) Group
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
干预措施: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)
Standard Care Group
Participants receive perioperative care according to the standard modified Enhanced Recovery After Surgery (ERAS) protocol without any acupuncture intervention.
干预措施: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)
Electroacupuncture (EA) Group
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.
干预措施: Electroacupuncture (EA) (Device)
Electroacupuncture (EA) Group
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.
干预措施: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)
Sham Electroacupuncture (SA) Group
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
干预措施: Sham Electroacupuncture (SA) (Device)
结局指标
主要结局
Time to First Postoperative Defecation
时间窗: From the end of surgery up to postoperative day 30.
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.
次要结局
- 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.)