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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chait Trapdoor caecostomie catheter | Experimental | Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter |
|
| Continuation of optimal medical therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chait Trapdoor caecostomie catheter | Device | implantation of the Chait Trapdoor caecostomie catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (Gastrointestinal Quality Of Life Index) | assessed by the Gastrointestinal Quality Of Life Index (GIQLI) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (Gastrointestinal Quality Of Life Index) | Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI) | 21 months |
| Evolution of the Quality of life (SF-36 score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France | |||
| CMRRF de Kerpape |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37803037 | Derived | Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y. |
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| continuation of optimal medical therapy | Drug | continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter |
|
|
Evolution of the SF-36 score
| 2 years |
| Constipation score (Kess score) | Evolution of the Kess score | 2 years |
| Incontinence score (Cleveland score) | Evolution of the Cleveland score | 2 years |
| Neurogenic bowel dysfunction score | Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries | 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 | 2 years |
| Constipation treatments | Type of constipation treatments taken by the patient during the study and analysis of compliance | 2 years |
| Complications | Reports of immediate or delayed complications | 2 years |
| Ploemeur |
| 56270 |
| France |
| CHU de Rouen | Rouen | France |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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