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

Constipation Clinical Trial

— ConstiCAPE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566746
• Other study ID #: RC15_0041
• Status: Completed
• Phase: N/A
• Start date: June 20, 2016
• Est. completion date: June 23, 2022

Study information

• Verified date: January 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• Chait Trapdoor caecostomie catheter
implantation of the Chait Trapdoor caecostomie catheter

Drug:
• continuation of optimal medical therapy
continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	CMRRF de Kerpape	Ploemeur
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (Gastrointestinal Quality Of Life Index)	assessed by the Gastrointestinal Quality Of Life Index (GIQLI)	1 year
Secondary	Quality of life (Gastrointestinal Quality Of Life Index)	Evolution of quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI)	21 months
Secondary	Evolution of the Quality of life (SF-36 score)	Evolution of the SF-36 score	2 years
Secondary	Constipation score (Kess score)	Evolution of the Kess score	2 years
Secondary	Incontinence score (Cleveland score)	Evolution of the Cleveland score	2 years
Secondary	Neurogenic bowel dysfunction score	Evolution of the Neurogenic bowel dysfunction score for patients with spina bifida and / or spinal cord injuries	2 years
Secondary	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
Secondary	Constipation treatments	Type of constipation treatments taken by the patient during the study and analysis of compliance	2 years
Secondary	Complications	Reports of immediate or delayed complications	2 years