The Efficacy of Antegrade and Retrograde Enemas in the Management of Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal: A Single-Centre, Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Success rate of ileostomy reversal
研究概览
简要总结
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.
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
- Single (Outcomes Assessor)
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
- •According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;
- •Age ≥ 18 years;
- •Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;
- •Expected to undergo ileostomy reversal surgery within 1-2 months;
- •Possesses normal cognitive and communication abilities;
- •Voluntarily participates in this study and has signed an informed consent form.
排除标准
- •American Society of Anesthesiologists (ASA) classification III or higher;
- •Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;
- •Mental disorders, long-term use of psychiatric drugs;
- •Contraindications to enemas.
结局指标
主要结局
Success rate of ileostomy reversal
时间窗: Two months after the last enema
low anterior resection syndrome score (LARS score)
时间窗: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points).
次要结局
- quality of sleep(Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.)
- bowel function(one month, two months, three months, and six months after stoma closure.)
- cancer patients' quality of life(one month, two months, three months, and six months after stoma closure.)
研究者
Hui Yang
Principal Investigator
Sichuan Cancer Hospital and Research Institute