Long-term Evaluation of Percutaneous Endoscopic Caecostomy in Refractory Constipation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
This observational monocentric study aims to evaluate the long-term effectiveness and tolerance of percutaneous endoscopic caecostomy (PEC) in patients with chronic refractory constipation. Follow-up data will be collected through phone interviews and standardized quality of life questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient
Received PEC at CHU de Nantes
Affiliated to French social security
Non-opposition obtained
Disqualifiers
No PEC placement
Protected adults or unable to respond
Refusal to participate
Trial population
Adults with refractory constipation treated with PEC at CHU Nantes.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Long-term success rate of PEC
Trial outcomes
Primary outcomes
1
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint (cf. Description Primary Outcomes 1 to 5): \- Catheter removal: positive if definitive removal without reimplantation at the time of the last update.
Time frame
At 2 years of follow-up.2
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpointt (cf. Description Primary Outcomes 1 to 5): \- GIQLI: positive if GIQLI ≥ +10 points vs. baseline.
Time frame
At 2 years of follow-up.3
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5): \- Kess: positive if Kess ≤ -5 points vs. baseline.
Time frame
At 2 years of follow-up.4
Evaluation of the long-term quality of life of patients
The assessment of the primary endpoint (long-term quality of life) is based on a composite endpoint: (cf. Description Primary Outcomes 1 to 5): \- Kess: positive if Kess ≤ -5 points vs. baseline.
Time frame
At 2 years of follow-up.Secondary outcomes
1
Assessment of quality of life using the SF-36 scale
Collection of SF36 scores at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study). Score between 0 and 100 ; the more elevated, better is the outcome.
Time frame
Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.2
Assessment of gastrointestinal quality of life using the GIQLI scale (Gastrointestinal Quality of Life Index)
Collection of GIQLI score at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study). Score between 0 and 144; the more elevated, better is the outcome.
Time frame
Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.3
Measures constipation severity using the KESS scale ((symptom scoring system for constipation)
Collection of Kess score at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study). Score between 0 and 39; the more elevated, worst is the outcome (severe constipation).
Time frame
Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.4
Assesses fecal incontinence using Cleveland scale
Collection of Cleveland score (Cleveland Clinic Fecal Incontinence Score (Jorge-Wexner, CCFIS)) at baseline and at 1, 3, 6, 9, and 12 months (previous Consticape study). Score between 0 and 20; the more elevated, worst is the outcome.
Time frame
Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.Sponsors and contacts
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Source ClinicalTrials.gov
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