Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment

Study Overview
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Brief Summary
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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.

Conditions
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Constipation

Intervention / Treatment
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* Device: Chait Trapdoor caecostomie catheter
* Drug: continuation of optimal medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chait Trapdoor caecostomie catheter<br>Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter | Device: Chait Trapdoor caecostomie catheter<br>* implantation of the Chait Trapdoor caecostomie catheter<br>|
| Active Comparator: Continuation of optimal medical therapy<br>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. | Device: Chait Trapdoor caecostomie catheter<br>* implantation of the Chait Trapdoor caecostomie catheter<br>Drug: continuation of optimal medical therapy<br>* continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter<br>* Other names: Chait Trapdoor caecostomie catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (Gastrointestinal Quality Of Life Index) | assessed by the Gastrointestinal Quality Of Life Index (GIQLI) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |