Clinical trial NCT02566746: Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life (Gastrointestinal Quality Of Life Index)
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life (Gastrointestinal Quality Of Life Index)
timeFrame: 21 months
measure: Evolution of the Quality of life (SF-36 score)
timeFrame: 2 years
measure: Constipation score (Kess score)
timeFrame: 2 years
measure: Incontinence score (Cleveland score)
timeFrame: 2 years
measure: Neurogenic bowel dysfunction score
timeFrame: 2 years
measure: Tolerance to the CTCC (Visual Analogue Scale)
timeFrame: 2 years
measure: Constipation treatments
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Ploemeur
country: France
facility: CMRRF de Kerpape
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References: