Prospective Randomized Cross-over Trial to Assess the Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome. SANLARS Trial (SAcral Neuromodulation for Low Anterior Resection Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Proportion of Responders of Low Anterior Resection Syndrome
研究概览
简要总结
Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life.
LARS treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves patients' symptoms and quality of life. However, no prospective randomized studies have supported this improvement.
This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients who have had an anterior rectal resection with sphincter preservation by any approach, with or without preoperative radiotherapy.
- •Patients with symptomatology of major anterior resection syndrome (>29 points on LARS score) including fecal incontinence, defecatory urgency, fecal fragmentation.
- •Period greater than one year since the last definitive surgery (rectal resection or ileostomy closure).
- •Period longer than one year in cases in which any other type of therapy has been performed for the anterior resection syndrome (for example: biofeedback, posterior tibial stimulation, physiotherapy, etc).
排除标准
- •Patients who refuse to sign informed consent or are unable to understand the study.
- •Patients with progression of the oncological disease.
- •Patients in initial stage IV (metastatic).
- •Patients with inflammatory bowel disease.
- •Patients with known irritable bowel prior to rectal surgery.
- •Patients who have undergone resection of other intestinal segments.
- •Patients with systemic neurological diseases with involvement of long pathways or spinal cord injury.
结局指标
主要结局
Proportion of Responders of Low Anterior Resection Syndrome
时间窗: 12 months
Low Anterior Resection Syndrome Score (LARS Score). This is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score). Patients should achieve 40% reduction from basal score.
次要结局
- Fecal incontinence(3 months, 6 months and 12 months)
- Sexual function(6 months and 12 months)
- Quality of life in patients with cancer(6 months and 12 months)
- Urinary function(6 months and 12 months)