The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of postoperative ileus
研究概览
简要总结
Chinese Medicine Ironing using Foeniculum vulgare has been applied in some departments to promote bowel function recovery, but the efficacy of ironing therapy remains uncertain after colorectal resection surgery.
详细描述
Postoperative ileus is one of the most common complications after abdominal surgery. It refers to obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal or nonabdominal surgery. When the expected period of gastrointestinal recovery time extends beyond what is acceptable, the patient is diagnosed as having a "pathologic" postoperative ileus (POI), which leads to patient discomfort, dissatisfaction, prolonged hospitalization and increased medical expenses. The incidence of POI is about 17%~24% after abdominal surgery. Chinese Medicine Ironing using Foeniculum vulgare has been applied in some departments to promote gastrointestinal function recovery as a empiric therapy. However, the definite efficacy of Foeniculum vulgare ironing therapy（FIT）is uncertain after colorectal resection surgery and whether FIT can reduce the incidence of POI remains unkonown.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 ~ 85 years old; sex is not limited.
- •Selective operation of colorectal partial resection.
- •Participants are volunteered to participate in this study, sign informed consent, and cooperated with follow-up.
排除标准
- •Emergency surgery.
- •Pregnant or lactating women.
- •ASA class 4 or 5 patients.
- •Patients with severe abdominal adhesions, which would cost more than 30 minutes to release. Patients with abdominal cocoon disease.
- •Patients with peritoneal metastasis or inflammatory bowel disease.
- •Patients undergoing enterostomy or total colectomy.
- •Patients simultaneously enrolled in any other competing clinical study.
研究组 & 干预措施
Ironing therapy
Stir-fry 500 grams of Foeniculum vulgare seeds until the aroma overflows. Put them into a cotton bag. Ironing therapy put the bag on abdomen after the temperature is suitable, 30 minutes per time, 4 times daily from 12 hours after surgery and last for 2 days. The medicine bag can be heated and reused after it cool down.
干预措施: Foeniculum Vulgare Seed Ironing (Drug)
结局指标
主要结局
Incidence of postoperative ileus
时间窗: 4 days after operation
The same panel defined "prolonged" postoperative ileus as the occurrence of two or more of the following signs and symptoms on postoperative day 4 or after: Nausea or vomiting, Inability to tolerate an oral diet over the preceding 24 hours, Absence of flatus over the preceding 24 hours, Abdominal distention.
Flatus time
时间窗: Up to 30 days after operation.
Time to faltus (hours from end of operation). Patients who had stool before any movement of gas were deemed to have an equal time to the time to flatus and first bowel movement.
次要结局
- Toleration of a low-residue diet(Up to 30 days after operation.)
- Toleration of drinking water(Up to 30 days after operation.)
- Duration of postoperative hospitalization(Up to 30 days after operation.)
- Short-term complications(Up to 30 days after operation.)
- Adverse events(Up to 30 days after operation.)
- Hospitalization costs(During postoperative hospitalization, up to 30 days after operation.)
- Pain assessment(During postoperative hospitalization, up to 30 days after operation.)
- Nausea and appetite assessment(During postoperative hospitalization, up to 30 days after operation.)
研究者
Ziqiang Wang,MD
professor
West China Hospital