Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Quality of life (Gastrointestinal Quality Of Life Index)
研究概览
简要总结
The investigators' study aims to compare the results of percutaneous endoscopic caecostomie (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to medical treatment. The primary endpoint will be the quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible complications. The patients included must meet the classification criteria of Rome III, have an elongated colonic transit time, have had a complete colonoscopy and be refractory to medical treatment including at least one stimulant laxative or suppositories or enemas retrograde.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient betwen 18 and 75 years old
- •Chronic constipation defined by the Rome III classification
- •Transit time with pellets made within 24 months preceding the inclusion visit indicating a transit time of at least 120 hours and/or with a Neurogenic bowel dysfunction ≥ 14 for patients with spina bifida and / or spinal cord injuries.
- •Colonoscopy made within the 5 years preceding the inclusion visit indicating the absence of colorectal organic obstacle
- •Anorectal manometry performed within 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation
- •GIQLI score <121 and Kess Questionnaire score> 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months.
- •Affiliation to a social security
- •- Chronic constipation defined by the Rome III classification
- •Transit time with pellets made within 24 months preceding the inclusion visit indicating an increase of at least 120 hours compared to normal
- •Colonoscopy made within the 24 months preceding the inclusion visit indicating the absence of colorectal organic obstacle
- •Anorectal manometry performed in the 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation
- •Score GIQLI love <121 and Kess Questionnaire score> 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months.
- •Affiliation to a social security scheme
- •Informed consent signed
排除标准
- •Severe obesity (BMI> 40)
- •History of surgical resection of colon
- •Hypothyroidism, electrolyte disorders, insulin-dependent diabetes
- •Acute decompensation of depressive syndrome
- •Immunosuppressive therapy
- •Disorders of hemostasis (TP <70%, APTT> 1.5, thrombocytopenia <70,000 / mm3)
- •Pregnant woman (positive serum beta-hCG) or breastfeeding
- •Adults under guardianship, curatorship or under court protection
- •Participation in another research protocol on the treatment of constipation
研究组 & 干预措施
Chait Trapdoor caecostomie catheter
Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter
干预措施: Chait Trapdoor caecostomie catheter (Device)
Continuation of optimal medical therapy
Patients randomized in this arm will continue this medical treatment of constipation with laxative and / or suppositories and / or enemas retrograde during 12 months.
At 12 months : patients will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter during 12 months.
干预措施: Chait Trapdoor caecostomie catheter (Device)
Continuation of optimal medical therapy
Patients randomized in this arm will continue this medical treatment of constipation with laxative and / or suppositories and / or enemas retrograde during 12 months.
At 12 months : patients will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter during 12 months.
干预措施: continuation of optimal medical therapy (Drug)
结局指标
主要结局
Quality of life (Gastrointestinal Quality Of Life Index)
时间窗: 1 year
assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
次要结局
- Quality of life (Gastrointestinal Quality Of Life Index)(21 months)
- Evolution of the Quality of life (SF-36 score)(2 years)
- Constipation score (Kess score)(2 years)
- Constipation treatments(2 years)
- Neurogenic bowel dysfunction score(2 years)
- Tolerance to the CTCC (Visual Analogue Scale)(2 years)
- Incontinence score (Cleveland score)(2 years)
- Complications(2 years)