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

NCT02566746 | Completed

• 1 other identifier: RC15_0041
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Quality of life (Gastrointestinal Quality Of Life Index)

  assessed by the Gastrointestinal Quality Of Life Index (GIQLI)

  1 year

Secondary Outcomes (8)

• Quality of life (Gastrointestinal Quality Of Life Index)

  21 months

• Evolution of the Quality of life (SF-36 score)

  2 years

• Constipation score (Kess score)

  2 years

• Incontinence score (Cleveland score)

  2 years

• Neurogenic bowel dysfunction score

  2 years

Study Arms (2)

Chait Trapdoor caecostomie catheter

EXPERIMENTAL

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

Device: Chait Trapdoor caecostomie catheter

Continuation of optimal medical therapy

ACTIVE COMPARATOR

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; Drug: continuation of optimal medical therapy

Interventions

Chait Trapdoor caecostomie catheter DEVICE

implantation of the Chait Trapdoor caecostomie catheter

Chait Trapdoor caecostomie catheter; Continuation of optimal medical therapy

continuation of optimal medical therapy DRUG

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

Also known as: Chait Trapdoor caecostomie catheter

Continuation of optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient betwen 18 and 75 years old
• Chronic constipation defined by the Rome III classification
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHU de Nantes

Nantes, 44093, France

Location

CMRRF de Kerpape

Ploemeur, 56270, France

Location

CHU de Rouen

Rouen, France

Location

Related Publications (1)

• 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.

  PMID: 37803037 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: June 20, 2016
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

FR (3)