Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Recovery of physical function
研究概览
简要总结
Background:
Patients who undergo laparoscopic surgical resection of colorectal cancer may experience various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation of daily activities (e.g., walking capacity). There is also a risk of post-operative complications and a prolonged hospital stay due to complications. Patients who underwent surgical resection may have experienced chronic pain, anxiety/depression, or diminished quality of life. The physical, psychological, and functional aspects of patients' disorders imply the necessity of multidisciplinary care, including complementary or traditional medicines such as acupuncture. This study aims to assess whether acupuncture treatment, combined with an enhanced recovery program after surgery in an inpatient care setting is effective than only an enhanced recovery program after surgery.
Objective:
To assess the effectiveness and safety of acupuncture combined with an enhanced recovery program after surgery to reduce postoperative symptoms and improve functional recovery and the patients' 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
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
- •Patients aged 18 to 75
- •American Society of Anesthesiologists Grade 1 to 2
- •Eastern Cooperative Oncology Group Grade 0 to 2
- •Written informed consents
排除标准
- •Pregnancy
- •Inflammatory bowel disease
- •Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
- •Resection of other organs for radical removal of colorectal cancer
- •Patients requiring enterolysis due to previous history of abdominal surgery
- •Obstructive colorectal cancer
- •Metastatic colorectal cancer
- •Cognitive impairment that may affect the patient's ability to complete the outcome assessments
- •Previous history of stroke
- •Previous history of sensitive reaction to acupuncture
- •Patients unable to cooperate with acupuncture treatments
- •Pacemaker implantation
- •Previous history of epilepsy
- •Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
- •Patients who have participated in other trials within 3 months
结局指标
主要结局
Recovery of physical function
时间窗: at 2 weeks after surgery
Recovery of physical function, as measured by the physical function domain of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 instrument
次要结局
- Time to tolerate soft diet(up to 1 week after surgery (an expected period of admission))
- Time to independent walk(up to 1 week after surgery (an expected period of admission))
- Quality of life measured by EORTC QLQ C30(at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery)
- Anxiety and depression(at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery)
- Incidence of nausea/vomiting(up to 1 week after surgery (an expected period of admission))
- Number of reinsertions of Foley catheter(up to 1 week after surgery (an expected period of admission))
- Use of medication(at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery)
- Postoperative complications(within 12 weeks after surgery)
- Adverse events related to acupuncture(within 12 weeks after surgery)
- Pain intensity(at 4, 12, 24, 48, 72 hours after surgery, at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, and at 4 weeks after surgery)
- Number of insertions of nasogastric tube(up to 1 week after surgery (an expected period of admission))
- Time to first removal of Foley catheter(up to 1 week after surgery (an expected period of admission))
- Serious adverse events(within 12 weeks after surgery)
- Time to first flatus(up to 1 week after surgery (an expected period of admission))
- Time to first defecation(up to 1 week after surgery (an expected period of admission))
- Number of clean intermittent catheterizations(up to 1 week after surgery (an expected period of admission))
- Patient's global assessment after surgery(at 4 weeks after surgery, at 12 weeks after surgery)
研究者
Gyung-Mo Son
Associate professor
Pusan National University Yangsan Hospital