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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
implantation of the Chait Trapdoor caecostomie catheter
continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
CHU de Nantes
Nantes, France
CMRRF de Kerpape
Ploemeur, France
CHU de Rouen
Rouen, France
Quality of life (Gastrointestinal Quality Of Life Index)
assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Time frame: 1 year
Quality of life (Gastrointestinal Quality Of Life Index)
Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
Time frame: 21 months
Evolution of the Quality of life (SF-36 score)
Evolution of the SF-36 score
Time frame: 2 years
Constipation score (Kess score)
Evolution of the Kess score
Time frame: 2 years
Incontinence score (Cleveland score)
Evolution of the Cleveland score
Time frame: 2 years
Neurogenic bowel dysfunction score
Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries
Time frame: 2 years
Tolerance to the CTCC (Visual Analogue Scale)
Evolution of the tolerance to the CHAIT Trapdoor caecostomy catheter on a skin and abdominal level with Visual Analogue Scale
Time frame: 2 years
Constipation treatments
Type of constipation treatments taken by the patient during the study and analysis of compliance
Time frame: 2 years
Complications
Reports of immediate or delayed complications
Time frame: 2 years
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