An observational study in Constipation and Refractory, sponsored by Nantes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Nantes University Hospital · Observational
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.
CONSTICAP 2 is a non-interventional cohort study conducted at CHU de Nantes. Patients who received a PEC between 2010 and 2022 will be contacted by phone at least two years after the procedure. Data will be collected using validated questionnaires (GIQLI, SF-36, etc.) to assess quality of life and treatment durability. The study builds on baseline and short-term data from the CONSTICAPE 1 cohort.
1,018 studies on the registry are indexed under Constipation; 140 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 129 observational studies indexed under Constipation.
Browse Constipation studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with refractory constipation treated with PEC at CHU Nantes.
Exclusion Criteria:
Composite outcome: (1) catheter still in place, (2) symptom improvement (GIQLI and KESS), and (3) positive answer to "Would you recommend this technique to someone with the same condition?"
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.
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.
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.
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.
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): \- Rule: composite success = 3/3 positive components.
Time frame: At 2 years of follow-up.
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.
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.
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.
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.
Measures neurogenic bowel dysfunction using NBD scale ((Neurogenic Bowel Dysfunction)
For patients with spina bifida and/or spinal cord injuries, Neurogenic Bowel Dysfunction (NBD) scores at 1, 3, 6, 9, and 12 months (previous Consticape study) Score between 0 and 47; the more elevated, worst is the outcome. Validated categories: 0-6 very minor, 7-9 minor, 10-13 moderate, ≥ 14 severe
Time frame: Baseline, 1, 3, 6, 9, and 12 months and at 2 years of follow-up.
Complications
Compilation of possible immediate or delayed complications during follow-up for up to 12 months (previous Consticape study)
Time frame: Throughout the 12-month follow-up.
Device Tolerance using EVA scale
Visual Analog Scale (VAS) for pain assessment at 15 days, 1, 3, 6, 9, and 12 months (previous Consticape study), collection of any complications and treatments taken by the patient (previous Consticape study and follow-up after at least 2 years) Score between 0 and 10; the more elevated, worst is the outcome. Commonly used categories: ≤ 3.4 mild, 3.5-7.4 moderate, ≥ 7.5 severe.
Time frame: 15 days, 1, 3, 6, 9, and 12 months and at 2 years
Plan to share: No — No individual participant data (IPD) will be shared.
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Nantes University Hospital