A Multicenter, Randomized Controlled Trial to Evaluate the Efficacy of Thread Embedding Acupuncture in Reducing Postoperative Ileus After Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to First Flatus
研究概览
简要总结
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of thread embedding acupuncture (TEA) in promoting gastrointestinal recovery after laparoscopic colorectal cancer surgery. The primary outcome is the time to first flatus. Secondary outcomes include time to first defecation, tolerance to oral intake, length of hospital stay, and patient-reported quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants were blinded to their group assignment. In the sham group, blunt needles were placed at the same acupoints using adhesive pads without skin penetration or electrical stimulation, simulating the appearance of real thread embedding. Outcome assessors and investigators responsible for data collection and analysis were also blinded to the group allocation. Care providers performing the procedure were not blinded due to the nature of the intervention.
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
- •Age 18-80 years Diagnosed with stage I-III colorectal cancer Scheduled for elective laparoscopic colorectal resection ASA Physical Status I-III Ability to provide informed consent
排除标准
- •History of prior major abdominal surgery Emergency or palliative surgery Combined organ resection or open conversion Severe postoperative complications (e.g., anastomotic leak, GI bleeding) Severe cardiac, hepatic, renal, or psychiatric comorbidities Refusal to undergo acupuncture
结局指标
主要结局
Time to First Flatus
时间窗: Up to 96 hours after surgery
Time (in hours) from the end of surgery to the first passage of gas per rectum
次要结局
未报告次要终点