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

NCT ID: NCT02566746

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-20
• Study Completion Date: 2022-06-23

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chait Trapdoor caecostomie catheter

Patients randomized in this arm will undergo percutaneous endoscopic caecostomy with Chait Trapdoor caecostomie catheter

Group Type: EXPERIMENTAL

Chait Trapdoor caecostomie catheter

Intervention Type: DEVICE

implantation of the Chait Trapdoor caecostomie catheter

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.

Group Type: ACTIVE_COMPARATOR

Chait Trapdoor caecostomie catheter

Intervention Type: DEVICE

implantation of the Chait Trapdoor caecostomie catheter

continuation of optimal medical therapy

Intervention Type: DRUG

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

Interventions

Chait Trapdoor caecostomie catheter

implantation of the Chait Trapdoor caecostomie catheter

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

Chait Trapdoor caecostomie catheter

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

CMRRF de Kerpape

Ploemeur, , France

CHU de Rouen

Rouen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37803037 (View on PubMed)

Other Identifiers

RC15_0041

Identifier Type: -

Identifier Source: org_study_id