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NCT02566746: ConstiCAPE

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

Completed NA Last updated 27 January 2023
What this trial tests

NA trial testing Chait Trapdoor caecostomie catheter in Constipation in 28 participants. Completed in 23 June 2022.

Timeline
20 June 2016
Primary endpoint
23 June 2022
23 June 2022

Quick facts

Lead sponsorNantes University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment28
Start date20 June 2016
Primary completion23 June 2022
Estimated completion23 June 2022
Sites3 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 75, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients.
    Lefèvre C, Le Roy C, Bessard A, Le Berre-Scoul C, et al · · 2023 · cited 9× · PMID 37803037 · DOI 10.1038/s41598-023-44057-y

Verify or expand the search:

Other recruiting trials for Constipation

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02566746.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing