The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure: A Single Center Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- The extent of low anterior resection syndrome
研究概览
简要总结
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.
详细描述
The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management.
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
- None
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
- •aged 18-85 years old
- •Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
- •rectal cancer confirmed by preoperative pathology
- •in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
- •prophylactic ileostomy.
排除标准
- •cannot complete treatment
- •the history of the anorectal surgery
- •preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
- •postoperative anastomotic fistula and stricture
- •during pregnancy or breastfeeding women
- •with uncontrolled seizures, central nervous system disease or a history of mental disorders
- •the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
- •clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
- •has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
- •organ transplantation requiring immunosuppressive therapy
- •serious uncontrolled repeated infections, or other serious with disease of control;
- •moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
- •emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
- •in screening the first 4 weeks received study medication or treatment (to participate in other test).
结局指标
主要结局
The extent of low anterior resection syndrome
时间窗: 1 month after discharge, and 3, 6, and 12 months after surgery
low anterior resection syndrome score（0-42，Higher scores indicate more severe symptoms）
次要结局
- the intestinal function recovery(up to 10 days after surgery)
- Concentration of C-reactive protein(up to 10 days after surgery)
- Quality of Life Questionnaire Core 30(1 month after discharge, and 3, 6, and 12 months after surgery)
- fecal incontinence(1 month after discharge, and 3, 6, and 12 months after surgery)
- Weight change after rehabilitation(From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months)
- The number of emergency visits or rehospitalizations related to stoma closure(1 year after surgery)
- the incidence of postoperative intestinal obstruction (POI)(1 year after surgery)