Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
研究概览
简要总结
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
详细描述
Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this original approach has been confirmed by several studies. New indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. Its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. Moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis.
Subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. In those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. This approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease.
The aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Ulcerative Colitis diagnosed on criteria Lennard Jones (31) for at least 1 year
- •E1 - E2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures)
- •resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-TNF)
- •Activity score >5 and endoscopic score >2
- •Absence of bacterial infection in progress (Clostridium difficile)
- •Affiliated with a social protection scheme and had signed an informed consent
排除标准
- •Severe forms requiring hospitalization an intravenous treatment or immediate surgery
- •infectious colitis or proctitis
- •Prednisone> 20 mg / d
- •Contraindications to the use of neuromodulator
- •Corticosteroid therapy by intravenous route
- •Pregnant women
- •Major Trust
研究组 & 干预措施
Neuromodulation
干预措施: InterStim II Neurostimulator Model 3058 (Device)
结局指标
主要结局
Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
时间窗: 8 weeks
Clinical and endoscopic remission as measured by the Mayo score ≤ 2 points without any criteria\> 1 point to week 8
次要结局
- Assess the Remission at Week 16 ( Mayo score)(16 weeks)
- Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)(16 weeks)
- Assess the biological response at Week 8 and Week 16 (Calprotectin)(16 weeks)
- Assess abdominal discomfort for weeks at Week 8 and Week 16(16 weeks)
- Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)(16 weeks)
- Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)(16 weeks)
- Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)(16 weeks)
- Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)(16 weeks)
- Evaluate the need for steroids at Week 8 and Week 16(16 weeks)
- Evaluate the cessation of rectal bleeding at Week 8, Week 16(16 weeks)
- Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16(16 weeks)
- Assess the histological response at Week 8 and Week 16 (Geboes Score)(16 weeks)
- Assess the biological response at Week 8 and Week 16 (C-reactive protein)(16 weeks)
- Evaluate the immunosuppressive drugs at Week 8 and Week 16(16 weeks)
- Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36)(16 weeks)