The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
详细描述
The hypothesis is that TCM can decrease the postoperative complications for rectal cancer. So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo. The intervention will be described below. Primary endpoint is postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Signed written consent form;
- •Age from 18 to 75 years old;
- •Pathological diagnosis as rectal adenocarcinoma;
- •undergo laparoscopic curative surgery;
- •Patients' TCM syndrome accords with thoses of spleen deficiency syndrome;
排除标准
- •Patients undergo non-curative surgeries;
- •Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control;
- •Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment;
- •Women who are pregnant or breastfeeding;
- •Participants have mental illness or have difficulty in language communication and are unable to complete the study;
- •Participants could not cooperate with this researcher for other reasons.
结局指标
主要结局
Postoperative complications
时间窗: from operation to 30 days after operation
Rates of the complications after curative surgery
次要结局
- recovery of urinary function(from removal of urinary catheter to 30 days after operation)
- Recovery of fart and bowel function(7 days after operation)
- The European Organization of Quality of Life Questionnaire-colorectal-29(30 days after operation)
- Changes of TCM symptoms(30 days after operation)
- Length of hospital stay(30 days after operation)
研究者
Aiwen Wu
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute
Peking University Cancer Hospital & Institute