Constipation
Conditions
Brief summary
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.
Interventions
DEVICEChait Trapdoor caecostomie catheter
implantation of the Chait Trapdoor caecostomie catheter
DRUGcontinuation of optimal medical therapy
continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (Gastrointestinal Quality Of Life Index) | 1 year | assessed by the Gastrointestinal Quality Of Life Index (GIQLI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the Quality of life (SF-36 score) | 2 years | Evolution of the SF-36 score |
| Constipation score (Kess score) | 2 years | Evolution of the Kess score |
| Incontinence score (Cleveland score) | 2 years | Evolution of the Cleveland score |
| Quality of life (Gastrointestinal Quality Of Life Index) | 21 months | Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI) |
| Tolerance to the CTCC (Visual Analogue Scale) | 2 years | Evolution of the tolerance to the CHAIT Trapdoor caecostomy catheter on a skin and abdominal level with Visual Analogue Scale |
| Constipation treatments | 2 years | Type of constipation treatments taken by the patient during the study and analysis of compliance |
| Complications | 2 years | Reports of immediate or delayed complications |
| Neurogenic bowel dysfunction score | 2 years | Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries |
Countries
France
Outcome results
None listed