Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
- Conditions
- Constipation
- Interventions
- Device: Chait Trapdoor caecostomie catheterDrug: continuation of optimal medical therapy
- Registration Number
- NCT02566746
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
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- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chait Trapdoor caecostomie catheter Chait Trapdoor caecostomie catheter Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter Continuation of optimal medical therapy Chait Trapdoor caecostomie catheter 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. Continuation of optimal medical therapy 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.
- Primary Outcome Measures
Name Time Method Quality of life (Gastrointestinal Quality Of Life Index) 1 year assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
- Secondary Outcome Measures
Name Time Method Quality of life (Gastrointestinal Quality Of Life Index) 21 months Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)
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
Constipation treatments 2 years Type of constipation treatments taken by the patient during the study and analysis of compliance
Neurogenic bowel dysfunction score 2 years Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries
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
Incontinence score (Cleveland score) 2 years Evolution of the Cleveland score
Complications 2 years Reports of immediate or delayed complications
Trial Locations
- Locations (3)
CHU de Nantes
🇫🇷Nantes, France
CHU de Rouen
🇫🇷Rouen, France
CMRRF de Kerpape
🇫🇷Ploemeur, France